Optimal Resources for Metabolic and Bariatric Surgery

2019 Standards

facs.org/mbsaqip AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS Optimal Resources for Metabolic and Bariatric Surgery 2019 Standards

Copyright © 2019 American College of Surgeons, 633 N. Saint Clair St., Chicago, IL 60611-3295. All rights reserved. Table Foreword ii MBSAQIP Designations and Accreditation Pathways vi of Contents Designations vii Designation Requirements Overview viii Accreditation Pathways x

Standard 1 Institutional Administrative Commitment 1 1.1 Administrative Commitment 3

Standard 2 Program Scope and Governance 5 2.1 Volume Criteria 7 2.2 Low Acuity Center Patient and Procedure 9 Selection 2.3 Ambulatory Surgery Center Patient and 10 Procedure Selection 2.4 Metabolic and Bariatric Surgery (MBS) Committee 11 2.5 Metabolic and Bariatric Surgery (MBS) Director 13 2.6 Metabolic and Bariatric Surgery (MBS) 15 Coordinator 2.7 Metabolic and Bariatric Surgery (MBS) Clinical 16 Reviewer 2.8 Obesity Medicine Director (OMD) 18

Standard 3 Facilities and Equipment Resources 21 3.1 Health Care Facility Accreditation 23 3.2 Facilities, Equipment, and Furniture 24 3.3 Designated Bariatric Unit 26 Standard 4 Standard 6 Personnel and Services Resources 29 Data Surveillance and Systems 59 4.1 Credentialing Guidelines for Metabolic and 31 6.1 Data Entry 61 Bariatric Surgeons 6.2 30-Day and Long-Term Follow-Up 62 4.2 MBSAQIP Surgeon Verification 33 6.3 Data Review 63 4.3 Metabolic and Bariatric Surgery Call Coverage 35 6.4 Obesity Medicine Data Collection 64 4.4 Staff Training 36 4.5 Multidisciplinary Team 37 Standard 7 4.6 Advanced Cardiovascular Life Support (ACLS) 38 Quality Improvement 67 4.7 Patient Stabilization 39 7.1 Adverse Event Monitoring 69 4.8 Critical Care Unit (CCU) / Intensive Care Unit 40 7.2 Quality Improvement Initiatives 70 (ICU) Services 7.3 Annual Compliance Reports (ACRs) 72 4.9 Anesthesia Services 41 4.10 Endoscopy Services 42 Standard 8 4.11 Diagnostic and Interventional Radiology Services 43 Education: Professional and Community Outreach 75 4.12 Specialty Services 44 8.1 Support Groups 77 4.13 Pediatric Medical Advisor (PMA) 45 4.14 Pediatric Behavioral Specialist 46 Accreditation Definitions 78 4.15 Children’s Hospital Service Requirements 47 Accreditation Process Overview 79 MBSAQIP Accreditation Process for Initial 79 Standard 5 Applicants Patient Care: Expectations and Protocols 49 MBSAQIP Reaccreditation Process for Renewal 79 5.1 Patient Education Pathways 51 Applicants 5.2 Patient Care Pathways 52 5.3 Written Transfer Agreement 53 5.4 Inpatient Admitting Privileges 54 5.5 Risk Assessment Protocol 55 5.6 Obesity Medicine Services 56 MBSAQIP-Accredited centers demonstrate an uncompromising pursuit of quality that has earned the confidence, respect and trust of patients making a commitment to healthier living.

It’s better for your patients. for your surgeons. for your center.

i Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons The Optimal Resources for Metabolic and Bariatric Surgery Foreword outlines requirements for facilities to follow when seeking accreditation. MBSAQIP Accreditation provides guidance The American College of Surgeons (ACS) and the American for facilities aiming to build the structure and outcomes Society for Metabolic and Bariatric Surgery (ASMBS) are expertise necessary to provide safe, efficacious, and high- pleased to offer the latest Standards for the Metabolic and quality care to all metabolic and bariatric patients. Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP®), a nationwide accreditation and quality improvement program for the treatment of metabolic and bariatric patients. The MBSAQIP builds upon the Background on ACS and ASMBS rich history of these organizations in advancing surgical patient care, and the previous success of their individual About the American College of Surgeons accreditation and quality improvement programs. The American College of Surgeons (ACS) is a scientific and educational organization of surgeons that was founded in Through their collaborative efforts, the ACS and the ASMBS are 1913 to raise the standards of surgical practice and improve confident that by working together with the facilities, physicians, the quality of care for all surgical patients. The College is and health care professionals who provide care to the more dedicated to the ethical and competent practice of surgery. than 18 million people in the United States who are affected Its achievements have significantly influenced the course of by obesity, they are able to answer the call to action to address scientific surgery in America and have established it as an obesity as a national public health priority and serve as the important advocate for all surgical patients. The College has medical home for all patients with obesity. more than 82,000 members and is the largest organization of surgeons in the world. For more information, visit facs.org. Currently, there are more than 800 MBSAQIP-Accredited centers in the United States and Canada, and multiple About the American Society for Metabolic and Bariatric international centers participating as Data Collection Surgery Centers. More than 200,000 bariatric cases are captured The American Society for Metabolic and Bariatric Surgery annually in the MBSAQIP Registry. (ASMBS) is the largest organization for metabolic and bariatric surgeons in the world, with more than 4,200 Multiple studies have examined patient safety in metabolic members. It is a not-for-profit organization that works to and bariatric surgery and support the value of accreditation. advance the science of metabolic and bariatric surgery. The An article in Surgical Endoscopy (July 2013) found that in- ASMBS is committed to educating medical professionals hospital mortality rates at accredited centers were more than and the lay public about metabolic and bariatric surgery, three times lower than the mortality rates at non-accredited including the associated risks and benefits, as a treatment centers (0.06% vs. 0.22%). University of California Irvine option for obesity. The ASMBS encourages its members to researchers conducting this study analyzed 277,760 metabolic investigate and discover new advances in metabolic and and bariatric procedures performed between 2006 and 2010. bariatric surgery while maintaining a steady exchange of Additionally, an October 2012 publication in the Journal of experience and ideas that may lead to improved surgical the American College of Surgeons showed nearly the same outcomes for patients with obesity. For more information, differences in mortality rates between accredited and non- visit asmbs.org. accredited academic metabolic and bariatric surgery centers (0.06% vs. 0.21%, respectively).

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery ii Metabolic and Bariatric Surgeon Contributors Acknowledgements Stacy Brethauer, MD, FACS, FASMBS Eric DeMaria, MD, FACS, FASMBS This 3rd version of the MBSAQIP Standards Manual Wayne English, MD, FACS, FASMBS is dedicated to Ronald “Ronnie” Clements, MD, FACS, Karen Flanders, MSN, CNP, CBN FASMBS. Matthew Hutter, MD, FACS, FASMBS Teresa LaMasters, MD, FACS, FASMBS As Co-Chair of the MBSAQIP Standards Committee, he Samer Mattar, MBBCh, FACS, FASMBS was instrumental in developing the inaugural version of Marc Michalsky, MD, FACS, FASMBS the Optimal Resources for Metabolic and Bariatric Surgery. John Morton, MD, FACS, FASMBS Memories of his warm personality, clinical excellence, and Richard Peterson, MD, FACS, FASMBS indomitable spirit will continue as an inspiration to all who Anthony Petrick, MD, FACS, FASMBS care for patients with obesity. David Provost, MD, FACS, FASMBS Aurora Pryor, MD, FACS, FASMBS Bruce Wolfe, MD, FACS, FASMBS

Obesity Medicine Physician Contributors Caroline Apovian, MD, FACP, FACN Louis Aronne, MD, FACP Scott Butsch, MD, MSc John Cleek, MD, FTOS Angela Fitch, MD, FACP Deborah Horn, DO, MPH Scott Kahan, MD, MPH Christopher Still, DO, FACN, FACP, FTOS

ACS Staff Contributors Clifford Y. Ko, MD, MSHS, FACS, Director, Division of Research and Optimal Patient Care Sameera Ali, MPH, Administrative Director, Division of Research and Optimal Patient Care Teresa Fraker, MS, RN, Program Administrator, MBSAQIP Paul Jeffers, BA, Verification Specialist, MBSAQIP

These Standards are intended solely as qualification criteria for MBSAQIP Accreditation. They do not constitute a standard for care and are not intended to replace the medical judgment of the surgeon or health care professional in individual circumstances.

In order for a center to be found compliant with the MBSAQIP Standards, the center must be able to demonstrate compliance with the entire Standard as outlined in the Definition and Requirements, Documentation, and Measure of Compliance sections under each Standard. The Documentation and Measure of Compliance sections under each Standard are intended to provide summary guidance on how compliance must be demonstrated but are not intended to stand alone or supersede the Definition and Requirements.

In addition to verifying compliance with the Standards as written in this manual, the MBSAQIP may consider other factors not stated herein when reviewing a center for accreditation and reserves the right to withhold accreditation on this basis.

iii Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery iv AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM MBSAQIP Designations and Accreditation Pathways This section provides a list of all designations offered by the MBSAQIP® as well as pathways to achieve full MBSAQIP accreditation.

Designations

Data Collection Center (not accredited)

Accredited Inpatient Center

MBSAQIP Comprehensive Center MBSAQIP Comprehensive Center with Adolescent Qualifications MBSAQIP Comprehensive Center with Obesity Medicine Qualifications MBSAQIP Comprehensive Center with Adolescent and Obesity Medicine Qualifications MBSAQIP Low Acuity Center MBSAQIP Adolescent Center

Accredited Outpatient Center

MBSAQIP Ambulatory Surgery Center

vii Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons MBSAQIP Comprehensive Center with Adolescent Designation Requirements Overview Qualifications MBSAQIP Adolescent Qualifications are required for facilities that provide care to patients who are younger than Data Collection Center 18 years of age. This qualification is separate and distinct from adult accreditation and is awarded to adult inpatient Participation as a Data Collection Center is only available to facilities to become MBSAQIP Comprehensive Centers with international centers and is not available to centers within the Adolescent Qualifications. United States and Canada. Centers within the United States 1. Center demonstrates compliance with all applicable and Canada must apply for MBSAQIP Accreditation. MBSAQIP Standards and successfully completes a site visit. Please see the MBSAQIP website for more information 2. Center performs a minimum of 50 bariatric stapling regarding Data Collection Center eligibility and procedures annually, and the MBS Clinical Reviewer participation: facs.org/quality-programs/mbsaqip enters data into the MBSAQIP Registry. 1. The MBS Director and program stakeholders must 3. Approved to perform all ASMBS-endorsed procedures. review the MBSAQIP International Data Collection 4. Approved to provide care to patients of all ages. Center Webinar. 2. A Metabolic and Bariatric Surgery (MBS) Clinical Applicable Standards: Reviewer is identified by the center and the MBS • Standard 1 Clinical Reviewer successfully completes training. • Standard 2.1; 2.4–2.7 3. The MBS Clinical Reviewer enters data into the • Standard 3 MBSAQIP Registry. • Standard 4.1–4.14 4. Center is not required to demonstrate compliance with • Standard 5.1–5.3 Standards. • Standard 6.1–6.3 5. No minimum annual case volume is required. • Standard 7 • Standard 8 Applicable Standards: None, not accredited MBSAQIP Comprehensive Center with Obesity Medicine Qualifications Accredited Inpatient Center MBSAQIP Obesity Medicine Qualifications are separate and distinct from surgical and procedural accreditation. MBSAQIP Comprehensive Center 1. Center demonstrates compliance with all applicable Only MBSAQIP Comprehensive Centers and MBSAQIP MBSAQIP Standards and successfully completes a site Comprehensive Centers with Adolescent Qualifications are visit. eligible to seek MBSAQIP Obesity Medicine Qualifications. 2. Center performs a minimum of 50 bariatric stapling 1. Center demonstrates compliance with all applicable procedures annually, and the MBS Clinical Reviewer MBSAQIP Standards and successfully completes a site enters data into the MBSAQIP Registry. visit. 3. Approved to perform all ASMBS-endorsed procedures. 2. Center performs a minimum of 50 bariatric stapling 4. Only approved to provide care to patients 18 years of procedures annually, and the MBS Clinical Reviewer age and older. enters data into the MBSAQIP Registry. 3. Approved to perform all ASMBS-endorsed procedures. Applicable Standards: 4. Only approved to provide care to patients 18 years of • Standard 1 age and older. • Standard 2.1; 2.4–2.7 • Standard 3 Applicable Standards: • Standard 4.1–4.12 • Standard 1 • Standard 5.1–5.3 • Standard 2.1; 2.4–2.8 • Standard 6.1–6.3 • Standard 3 • Standard 7 • Standard 4.1–4.12 • Standard 8 • Standard 5.1–5.3; 5.6 • Standard 6 • Standard 7 • Standard 8

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery viii MBSAQIP Comprehensive Center with Adolescent and MBSAQIP Adolescent Center Obesity Medicine Qualifications MBSAQIP Adolescent Qualifications are required for MBSAQIP Adolescent Qualifications are required for facilities that provide care to patients who are younger than facilities that provide care to patients who are younger than 18 years of age. This qualification is separate and distinct 18 years of age. This qualification is separate and distinct from adult accreditation and is awarded to children’s from adult accreditation and is awarded to adult inpatient hospitals to become MBSAQIP Adolescent Centers. facilities to become MBSAQIP Comprehensive Centers with 1. Center demonstrates compliance with all applicable Adolescent Qualifications. MBSAQIP Standards and successfully completes a site visit. MBSAQIP Obesity Medicine Qualifications are separate and 2. Center performs a minimum of 15 stapling procedures distinct from surgical and procedural accreditation. annually, otherwise a MBSAQIP Verified Surgeon must be present as a co-surgeon on each case, and the Only MBSAQIP Comprehensive Centers and MBSAQIP MBS Clinical Reviewer enters data into the MBSAQIP Comprehensive Centers with Adolescent Qualifications are Registry. eligible to seek MBSAQIP Obesity Medicine Qualifications. 3. Approved to perform all ASMBS-endorsed procedures. 1. Center demonstrates compliance with all applicable 4. Only approved to provide care to patients younger than MBSAQIP Standards and successfully completes a site 18 years of age. visit. 2. Center performs a minimum of 50 bariatric stapling Applicable Standards: procedures annually, and the MBS Clinical Reviewer • Standard 1 enters data into the MBSAQIP Registry. • Standard 2.1; 2.4–2.7 3. Approved to perform all ASMBS-endorsed procedures. • Standard 3 4. Approved to provide care to patients of all ages. • Standard 4 • Standard 5.1–5.3 Applicable Standards: • Standard 6.1–6.3 • Standard 1 • Standard 7 • Standard 2.1; 2.4–2.8 • Standard 8 • Standard 3 • Standard 4.1–4.14 • Standard 5.1–5.3; 5.6 Accredited Outpatient Center • Standard 6 • Standard 7 MBSAQIP Ambulatory Surgery Center • Standard 8 MBSAQIP Accreditation for Ambulatory Surgery Centers is separate and distinct as an outpatient facility designation that MBSAQIP Low Acuity Center provides care for metabolic and bariatric patients 18 years of 1. Center demonstrates compliance with all applicable age and older. MBSAQIP Standards and successfully completes a site 1. Center demonstrates compliance with all applicable visit. MBSAQIP Standards and successfully completes a site 2. Center performs a minimum of 25 bariatric procedures visit. annually, and the MBS Clinical Reviewer enters data 2. Center performs a minimum of 25 bariatric procedures into the MBSAQIP Registry. annually, and the MBS Clinical Reviewer enters data 3. Center follows the Low Acuity Center Patient and into the MBSAQIP Registry. Procedure Selection criteria outlined in Standard 2.2. 3. Center follows the Ambulatory Surgery Center Patient 4. Only approved to provide care to patients 18 years of and Procedure Selection criteria outlined in Standard age and older. 2.3. 4. Only approved to provide care to patients 18 years of Applicable Standards: age and older. • Standard 1 • Standard 2.1, 2.2; 2.4–2.7 Applicable Standards: • Standard 3 • Standard 1 • Standard 4.1–4.12 • Standard 2.1; 2.3–2.7 • Standard 5.1–5.3 • Standard 3.1–3.2 • Standard 6.1–6.3 • Standard 4.1–4.12 • Standard 7 • Standard 5.1–5.5 • Standard 8 • Standard 6.1–6.3 • Standard 7 • Standard 8 ix Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Accreditation Pathways

*The applicable Standards for each designation level are found in the Designation Requirements Overview.

Data Collection Center MBSAQIP Comprehensive Center with Adolescent and • Only available to international centers outside the Obesity Medicine Qualifications United States and Canada • Center demonstrates compliance with all applicable • Compliance with Standards not required MBSAQIP Standards • No minimum annual case volume required • Performs ≥ 50 bariatric stapling procedures • MBS Clinical Reviewer completes training and enters annually data into the MBSAQIP Registry • MBS Clinical Reviewer completes training and enters • Center is not accredited data into the MBSAQIP Registry MBSAQIP Comprehensive Center • Approved to perform all ASMBS-endorsed procedures • Center demonstrates compliance with all applicable • Adult and adolescent patients MBSAQIP Standards • Site Visit required • Performs ≥ 50 bariatric stapling procedures MBSAQIP Low Acuity Center annually • MBS Clinical Reviewer completes training and enters • Center demonstrates compliance with all applicable data into the MBSAQIP Registry MBSAQIP Standards • Approved to perform all ASMBS-endorsed • Performs ≥ 25 bariatric procedures annually procedures • MBS Clinical Reviewer completes training and enters • Adult patients only data into the MBSAQIP Registry • Site Visit required • Center follows the Low Acuity Center Patient and MBSAQIP Comprehensive Center with Adolescent Procedure Selection criteria Qualifications • Adult patients only • Site Visit required • Center demonstrates compliance with all applicable MBSAQIP Adolescent Center MBSAQIP Standards • Performs ≥ 50 bariatric stapling procedures • Center demonstrates compliance with all applicable annually MBSAQIP Standards • MBS Clinical Reviewer completes training and enters • Performs ≥ 15 bariatric stapling procedures annually data into the MBSAQIP Registry or utilizes a MBSAQIP Verified co-surgeon • Approved to perform all ASMBS-endorsed • MBS Clinical Reviewer completes training and enters procedures data into the MBSAQIP Registry • Adult and adolescent patients • Approved to perform all ASMBS-endorsed • Site Visit required procedures MBSAQIP Comprehensive Center with Obesity • Adolescent patients only Medicine Qualifications • Site Visit required MBSAQIP Ambulatory Surgery Center • Center demonstrates compliance with all applicable MBSAQIP Standards • Center demonstrates compliance with all applicable • Performs ≥ 50 bariatric stapling procedures MBSAQIP Standards annually • Performs ≥ 25 bariatric procedures annually • MBS Clinical Reviewer completes training and enters • MBS Clinical Reviewer completes training and enters data into the MBSAQIP Registry data into the MBSAQIP Registry • Approved to perform all ASMBS-endorsed • Center follows the Ambulatory Surgery Center Patient procedures and Procedure Selection criteria • Adult patients only • Adult patients only • Site Visit required • Site Visit required

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery x AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 1 Institutional Administrative Commitment Standard 1 | Institutional Administrative Commitment

Rationale Full support and continuous commitment from institutional leadership is vital to maintaining a MBSAQIP-Accredited center. Resource allocation (such as equipment, personnel, and administrative support), a commitment to patient safety, and an enduring focus on continuous quality improvement are the hallmarks of strong institutional administrative support which help facilitate the success of MBSAQIP-Accredited centers.

2 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Institutional Administrative Commitment | Standard 1

1.1 Administrative Commitment

Definition and Requirements

Centers seeking MBSAQIP Accreditation must provide a letter from facility leadership (Chief Executive Officer or equivalent) demonstrating the institution’s current and continuous administrative commitment to the MBSAQIP- Accredited center. The letter must address, at a minimum, the following topics: • A high-level description of the metabolic and bariatric surgery program at the facility a. Metabolic and bariatric program leadership b. Annual volume of metabolic and bariatric procedures c. Metabolic and bariatric procedure mix d. Commitment to multidisciplinary care • All quality improvement initiatives, specific to metabolic and bariatric patient care, implemented in the most recent 12 months • Involvement and support from facility leadership for the metabolic and bariatric surgery program • Current and future financial investments in the metabolic and bariatric surgery program

Documentation

• A letter from facility leadership demonstrating the institution’s current and continuous administrative commitment to the MBSAQIP-Accredited center.

Measure of Compliance

• Provides documentation of a letter from facility leadership (Chief Executive Officer or equivalent) demonstrating the institution’s current and continuous administrative commitment to the MBSAQIP- Accredited center as outlined above.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 3 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 2 Program Scope and Governance Standard 2 | Program Scope and Governance

Rationale All MBSAQIP-Accredited centers must maintain sufficient annual case volume based on their designation level, as outlined below in Standard 2.1. Additionally, accredited centers must follow any patient and procedure selection criteria specific to their designation level.

Every metabolic and bariatric procedure (open, laparoscopic, hand-assisted, robotic, or endoscopic) performed for the treatment of metabolic or obesity- related diseases at a MBSAQIP-Accredited center must be entered into the MBSAQIP Registry. Please refer to Standard 6.1 for further details.

The facility and its medical staff provide the structure, process, and personnel to obtain and maintain the quality standards of the MBSAQIP in caring for metabolic and bariatric patients. The administrative and medical staff must commit to broad cooperation in order to improve the quality of metabolic and bariatric patient care provided at the center.

6 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

2.1 Volume Criteria

Definition and Requirements Designation Volume Criteria Data Collection No volume requirement—not All centers seeking MBSAQIP Accreditation must maintain Center accredited sufficient annual case volume based on their designation Designations For Inpatient Centers level, as outlined below. Comprehensive A minimum of 50 stapling procedures Center annually—adult patients only All centers must follow the requirements outlined in Standard 6.1 regarding data entry into the MBSAQIP Comprehensive A minimum of 50 stapling procedures Registry, and the requirements for Institutional Review Board Center with annually—adult and adolescent (IRB) approval or exemption for primary procedures that Adolescent patients are not endorsed by the American Society for Metabolic and Qualifications Bariatric Surgery (ASMBS). The ASMBS list of endorsed Comprehensive A minimum of 50 stapling procedures procedures is available on the ASMBS website, asmbs.org. Center with annually—adult patients only Obesity Medicine Primary procedures that are not endorsed by the ASMBS Qualifications are eligible to count toward the center’s annual accreditation Comprehensive A minimum of 50 stapling procedures volume as long as the requirements for IRB approval or Center with annually—adult and adolescent exemption are followed. These requirements are outlined in Adolescent and patients Standard 6.1 Obesity Medicine Qualifications Emerging evidence from the MBSAQIP Registry suggests Low Acuity A minimum of 25 bariatric that both surgeon and facility volume are significantly related Center procedures annually and must adhere to 30-day morbidity in bariatric surgery. To emphasize the to Low Acuity Center Patient and importance of annual case volume for procedures with the Procedure Selection (Standard 2.2)— highest degree of surgical complexity and technical difficulty, adult patients only the MBSAQIP recommends that centers performing anastomotic procedures for the treatment of metabolic or Adolescent Center A minimum of 15 stapling procedures obesity-related diseases maintain a minimum volume of 25 annually—adolescent patients only anastomotic procedures per year. This recommendation is not a requirement for Standards compliance. Centers performing fewer than 15 stapling procedures annually require Terminology a co-surgeon present for each case, as Stapling Procedures: MBSAQIP defines a stapling procedure outlined in Standard 4.15 as any procedure involving the use of a surgical stapler for the Designation For Outpatient Centers anastomosis or resection of any part of the gastrointestinal Ambulatory A minimum of 25 bariatric (GI) tract. Procedures involving a hand-sutured anastomosis Surgery Center procedures annually and must adhere are also included in this procedure category. to Ambulatory Surgery Center Patient and Procedure Selection (Standard Adult Patients: Any metabolic and bariatric patient 18 years 2.3)—adult patients only of age and older.

Adolescent Patients: Any metabolic and bariatric patient younger than 18 years of age.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 7 Standard 2 | Program Scope and Governance

INITIAL APPLICANTS must meet all applicable Standards for the designation level being sought within the most recent 12 months prior to applying for accreditation. Initial Applicants are not required to wait 12 months to apply if the center meets the application criteria sooner. For any Standard that requires 3 years of documentation, Initial Applicants are only required to document compliance within the most recent 12 months.

RENEWAL APPLICANTS must maintain continuous compliance with all applicable Standards. Continuous compliance with the MBSAQIP Standards will be evaluated every three years with a site visit as a component of the triennial reaccreditation cycle. Renewal Applicants are allowed to demonstrate compliance with the annual case volume requirements by averaging their annual case volume over the triennial reaccreditation cycle to meet the minimum requirements outlined above.

Documentation

• Case logs from the facility and/or physician records for all metabolic and bariatric procedures.

Measure of Compliance

• Provides documentation of an administrative data file and/or physician records to verify that the center meets the volume requirements for the designation level sought. • Provides proof that the center follows the patient and procedure selection criteria for their designation level.

8 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

2.2 Low Acuity Center Patient and Procedure Selection

Introducing New Metabolic and Bariatric Procedures Definition and Requirements Low Acuity Centers introducing new metabolic and bariatric procedures must conduct specific education for all personnel Low Acuity Centers must comply with the Low Acuity (including surgeons covering call) involved in the care of Center patient and procedure selection criteria outlined metabolic and bariatric patients prior to performing any new below. procedure. Education must be tailored specifically to the new metabolic and bariatric procedure being introduced to the Patient Selection Criteria center. This education must include, at minimum: 1. Age ≥ 18 and < 65 years 1. Formal training regarding a basic understanding of the 2. Males with a BMI < 55 and females with a BMI < 60 procedure being introduced, including the risks and 3. Patients without: benefits of the procedure a. Organ failure (for example, severe congestive heart 2. Signs and symptoms of postoperative complications failure, end-stage renal disease, severe liver disease, 3. A basic understanding of the management and care etc.) of metabolic and bariatric patients by a review of the b. An organ transplant center’s clinical pathways and protocols c. Significant cardiac or pulmonary impairment 4. Patients must not be a candidate on a transplant list 5. Patients must be ambulatory Documentation

Procedure Selection • Case logs, chart review during a site visit, and/or Low Acuity Centers are approved to perform primary MBSAQIP data validation confirming appropriate metabolic and bariatric procedures. All patients must have patient and procedure selection. no previous surgical history for the treatment of metabolic or • Staff education for newly introduced metabolic and obesity-related diseases. bariatric procedures.

Low Acuity Centers are only approved to perform the revisional metabolic and bariatric surgical procedures Measure of Compliance outlined below, and revisional metabolic and bariatric surgical procedures classified as anemergent case.* • Provides proof that patient and procedure selection fall Revisional metabolic and bariatric surgical procedures within the Low Acuity Center requirements outlined include any procedure performed for the purposes of weight above. loss at any time frame following a previous metabolic • Provides documentation that the education for center and bariatric surgical procedure. Low Acuity Centers are personnel, as outlined above, is provided prior to approved to perform the following revisional procedures: performing new metabolic and bariatric procedures. a. Adjustable gastric banding, replacement, and repositioning b. Adjustable gastric band and/or port removal c. Port revision

*Emergent case definition: An emergent case is usually performed within a short interval of time between patient diagnosis or the onset of related preoperative symptomatology. It is understood that the patient’s well-being and outcome is potentially threatened by unnecessary delay and the patient’s status could deteriorate unpredictably or rapidly. The principal operative procedure must be performed during the hospital admission for the diagnosis. Patients who are discharged after diagnosis and return for an elective, semi-elective, or urgent procedure related to the diagnosis are not considered to have had an emergent case.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 9 Standard 2 | Program Scope and Governance

2.3 Ambulatory Surgery Center Patient and Procedure Selection

Patients who are discharged after diagnosis and return for Definition and Requirements an elective, semi-elective, or urgent procedure related to the diagnosis are not considered to have had an emergent case. Ambulatory Surgery Centers must comply with the Ambulatory Surgery Center patient and procedure selection Introducing New Metabolic and Bariatric Procedures criteria outlined below. Ambulatory Surgery Centers introducing new metabolic and bariatric procedures must conduct specific education for all Patient Selection Criteria personnel (including surgeons covering call) involved in the 1. Age ≥ 18 and < 65 years care of metabolic and bariatric patients prior to performing 2. Males with a BMI < 55 and females with a BMI < 60 any new procedure. Education must be tailored specifically to 3. Patients without: the new metabolic and bariatric procedure being introduced a. Organ failure (for example, severe congestive heart to the center. This education must include, at minimum: failure, end-stage renal disease, severe liver disease, 1. Formal training regarding a basic understanding of the etc.) procedure being introduced, including the risks and b. An organ transplant benefits of the procedure c. Significant cardiac or pulmonary impairment 2. Signs and symptoms of postoperative complications 4. Patients must not be a candidate on a transplant list 3. A basic understanding of the management and care 5. Patients must be ambulatory of metabolic and bariatric patients by a review of the center’s clinical pathways and protocols Procedure Selection Ambulatory Surgery Centers are approved to perform primary metabolic and bariatric procedures. Documentation

Ambulatory Surgery Centers are only approved to perform • Case logs, chart review during a site visit, and/or the revisional metabolic and bariatric surgical procedures MBSAQIP data validation confirming appropriate outlined below, and revisional metabolic and bariatric patient and procedure selection. surgical procedures classified as an emergent case.* • Staff education for newly introduced metabolic and Revisional metabolic and bariatric surgical procedures bariatric procedures. include any procedure performed for the purposes of weight loss at any time frame following a previous metabolic and bariatric surgical procedure. Ambulatory Surgery Centers are Measure of Compliance approved to perform the following revisional procedures: a. Adjustable gastric banding, replacement, and • Provides proof that patient and procedure selection fall repositioning within the Ambulatory Surgery Center requirements b. Adjustable gastric band and/or port removal outlined above. c. Port revision • Provides documentation that the education for center d. Adjustable gastric band to sleeve gastrectomy personnel, as outlined above, is provided prior to performing new metabolic and bariatric procedures. To emphasize the importance of annual case volume for • Provides documentation of an administrative data procedures with a higher degree of surgical complexity, file and/or physician records to verify that the center Ambulatory Surgery Centers performing adjustable gastric performs a minimum of 50 stapling procedures per year, band to sleeve gastrectomy revisions must perform a if the center is performing adjustable gastric band to minimum of 50 stapling procedures per year. sleeve gastrectomy revisions.

*Emergent case definition: An emergent case is usually performed within a short interval of time between patient diagnosis or the onset of related preoperative symptomatology. It is understood that the patient’s well- being and outcome is potentially threatened by unnecessary delay and the patient’s status could deteriorate unpredictably or rapidly. The principal operative procedure must be performed during the hospital admission for the diagnosis.

10 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

2.4 Metabolic and Bariatric Surgery (MBS) Committee

There must be a minimum of three MBS Committee Definition and Requirements meetings each year. At least one of these MBS Committee meetings must be an annual comprehensive review meeting The center must establish a single, unified MBS Committee to evaluate the following: consisting of, at a minimum, the following members: • Quality improvement initiatives (Standard 7.2) • The MBS Director • Procedural volumes (Standard 2.1) • The MBS Coordinator • Patient care pathways (Standard 5.2) • The MBS Clinical Reviewer • Procedural outcomes (Standards 6.3 and 7.1) • All surgeons and proceduralists at the center performing • Compliance with all applicable MBSAQIP Standards procedures for the treatment of metabolic or obesity- related diseases At minimum, all surgeons and proceduralists at the center • Representative(s) of the facility’s administration who performing procedures for the treatment of metabolic or are involved in the care or oversight of metabolic and obesity-related diseases are required to attend the annual bariatric patients comprehensive review meeting, unless a written excuse is provided to the MBS Director. Excuses must be kept on file If a center is accredited with Adolescent Qualifications, the for review by the MBSAQIP to determine reasonableness (for center must establish a Pediatric Medical Advisor (PMA). example, patient, family, or personal emergency). The PMA must be a member of the MBS Committee. The responsibilities of the PMA and their involvement in the For surgeons seeking Metabolic and Bariatric Surgeon MBS Committee are outlined in Standard 4.13. Verification, as outlined in Standard 4.2, the annual comprehensive review meeting of the MBS Committee is If a center is accredited with Obesity Medicine Qualifications, allowed to count as one of the two required annual quality the center must establish an Obesity Medicine Director meetings. Only one annual comprehensive review meeting (OMD). The OMD must be a member of the MBS per year is allowed to count as a quality meeting for each Committee. The responsibilities of the OMD and their surgeon seeking verification. All other MBS Committee involvement in the MBS Committee are outlined in meetings do not count as quality meetings for the purposes Standards 2.8, 5.6, and 6.4. of surgeon verification.

The MBS Committee is considered the primary forum for For the remaining meetings that are not the annual continuous quality improvement, as outlined in Standard comprehensive review meeting, the members required to 7. The MBS Committee provides a confidential setting for attend depend on the subject matter of the meeting. At a sharing best practices, responding to adverse events, and minimum, the attending surgeon or proceduralist must fostering a culture to improve patient care. All surgical be in attendance if any aspect of care regarding one of practices performing metabolic and bariatric procedures their patients is discussed at a meeting. Accordingly, the at the center must participate in these initiatives in a MBS Committee will determine additional attendance collaborative manner, focusing on improved quality of care requirements for all active metabolic and bariatric surgeons for metabolic and bariatric patients. Official meeting minutes and proceduralists. A metabolic and bariatric surgeon are required to document that the MBS Committee has or proceduralist from each practice must serve as a reviewed and discussed adverse events and patient outcomes. representative at each of the three required meetings and Specific details of these discussions are not mandatory to attend either in person or by remote access in accordance fulfill this requirement and meeting minutes must be kept with the MBS Committee requirements. in accordance with all laws regarding confidentiality and HIPAA compliance. The MBS Committee must carry out all the duties enumerated here, in addition to any other responsibilities outlined in other Standards.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 11 Standard 2 | Program Scope and Governance

Documentation

• Official minutes for all MBS Committee meetings. • Proof of attendance for all metabolic and bariatric surgeons and proceduralists at the annual comprehensive review meeting.

Measure of Compliance

• Provides documentation of meeting minutes, including date, agenda, and attendance records, for the minimum of three MBS Committee meetings. • Provides documentation that all actively participating metabolic and bariatric surgeons and proceduralists attended the annual comprehensive review meeting, unless excused by the MBS Director.

12 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

2.5 Metabolic and Bariatric Surgery (MBS) Director

the center, as determined by the MBS Committee. Definition and Requirements Formal education and written protocols to nursing staff, surgeons, and proceduralists detailing the rapid The MBS Director must be an actively practicing metabolic communication and basic response to critical patient and bariatric surgeon and have full privileges and findings is specifically required to minimize delays in credentials to perform metabolic and bariatric surgery at the the diagnosis and treatment of serious adverse events. accredited center. A single individual must fill the position 5. The MBS Director, in conjunction with the MBS of MBS Director at a MBSAQIP-Accredited center. In Committee, is responsible for determining the inclusion conjunction with the MBS Committee and the institution’s and exclusion criteria, including weight and/or BMI administration, the MBS Director organizes, integrates, and limits, for metabolic and bariatric patients who receive leads all metabolic and bariatric surgery-related services care at the center. These criteria include the types of throughout the accredited center. The MBS Director must be procedures performed and the acuity and risk of all a MBSAQIP Verified Surgeon as described in Standard 4.2. patients relative to the services the center can safely If a center loses or changes its MBS Director for any reason, provide. These recommendations must be provided the center must notify the MBSAQIP within 30 days. In this to the appropriate institutional body responsible event, the center must establish a new MBS Director. for medical oversight (for example, credentialing, department of surgery, medical staff). Furthermore, if Specific responsibilities of the MBS Director include: necessary, the MBS Director submits recommendations 1. The MBS Director chairs the MBS Committee and must from the MBS Committee to the appropriate attend at least two of the three required meetings, one institutional administrative body relative to the scope of which must be the annual comprehensive review of metabolic and bariatric practice of each individual meeting, as well as the majority of all other meetings. surgeon and proceduralist based on that provider’s 2. The MBS Director, in conjunction with the MBS experience, training, and outcomes. Committee, is responsible for: 6. The MBS Director is responsible for overseeing the –– Overseeing the accreditation process and ensuring process (as determined by the MBS Committee) by continuous compliance with all applicable which emerging technologies and procedures will MBSAQIP Standards. be safely introduced at the center, with adequate –– Contacting the MBSAQIP within 30 days if the patient protection, oversight (including Institutional center falls out of compliance with any MBSAQIP Review Board [IRB] approval or IRB exemption when Standard or there is any substantive change in the indicated), and associated outcomes reporting. center. 7. The MBS Director is responsible for institution- –– Providing a response to MBSAQIP inquiries within wide communication of metabolic and bariatric- 30 days. related policies established by the MBS Committee. 3. The MBS Director, in conjunction with the MBS Communication with all appropriate personnel through Committee, must ensure compliance with outcomes formal metabolic and bariatric team meetings is a basic data collection for all metabolic and bariatric quality and safety improvement effort. procedures performed at the center, as well as leading 8. The MBS Director, representing the decision of the quality improvement initiatives. The MBS Director, in MBS Committee, is responsible for reporting to the conjunction with the MBS Committee, is responsible appropriate institutional entities (for example, chief of for: surgery, credentialing committee, medical staff, risk –– Development of quality standards management, etc.) significant ethical and/or quality –– Evaluation of surgical and procedural outcomes deviations by surgeons and proceduralists performing –– Development of specific quality improvement metabolic and bariatric procedures at the center and, initiatives in response to adverse events while when appropriate, plans for remediation or formal consistently improving the structure, process, and recommendations to limit or redact privileges. outcomes of the center 9. The institution’s organizational framework must 4. The MBS Director, in conjunction with the MBS incorporate the MBS Director position. The MBS Committee, is also responsible for overseeing the Director must have a job description, contract, or education of relevant staff in the various aspects of agreement that provides the authority and resources to metabolic and bariatric patient care with a focus on fulfill the duties listed above. patient safety and recognition of complications. The 10. The MBS Director must be present and actively MBS Director leads the standardization and integration participate in each MBSAQIP site visit for their current of metabolic and bariatric patient care throughout center(s).

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 13 Standard 2 | Program Scope and Governance

Documentation

• Metabolic and bariatric surgery privileges and credentials of the MBS Director. • MBS Committee meeting attendance records for the MBS Director. • The MBS Director qualifies as a MBSAQIP Verified Surgeon. (Surgeon verification is confirmed during the site visit by demonstrating compliance with Standard 4.2). • MBS Committee meeting minutes that document the MBS Director is leading the design and implementation of quality improvement initiatives. • A job description, contract, or agreement for the MBS Director position.

Measure of Compliance

• Provides documentation of the MBS Director’s privileges and credentials. • Provides documentation of meeting minutes showing that the MBS Director has attended at least the minimum number of required MBS Committee meetings as outlined above. • Provides proof that the MBS Director is a MBSAQIP Verified Surgeon (see Standard 4.2 for full details). • Provides documentation of MBS Committee meeting minutes that prove the MBS Director is leading the design and implementation of quality improvement initiatives. • Provides a job description, contract, or agreement for the MBS Director documenting that the MBS Director position is fully integrated into the institution’s organizational framework and has the authority and resources to fulfill all duties as outlined in items 1–10 above.

14 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

2.6 Metabolic and Bariatric Surgery (MBS) Coordinator

The MBS Coordinator must be present and actively Definition and Requirements participate in each MBSAQIP site visit for their current center(s). MBSAQIP-Accredited centers must have a designated MBS Coordinator who assists and works directly with the MBS Director. The MBS Coordinator must be a licensed or Documentation registered health care professional.* The center is allowed to have multiple MBS Coordinators, but a single individual • A job description or contract for the MBS Coordinator must serve as a liaison between the center and the MBSAQIP. position. The MBS Coordinator is also allowed to fill the role of the • MBS Committee meeting minutes documenting MBS Clinical Reviewer (see Standard 2.7) as long as this participation by the MBS Coordinator. individual does not document in patients’ medical records. If • The health care license or registration of the MBS a center loses or changes its MBS Coordinator for any reason, Coordinator.* the center must notify the MBSAQIP within 30 days. In this event, the center must establish a new MBS Coordinator. Measure of Compliance The MBS Coordinator administrates the MBS Committee and must attend at least two of the three required meetings, • Provides a job description or contract documenting that one of which must be the annual comprehensive review the MBS Coordinator position is fully integrated into meeting, as well as the majority of all other meetings. The the organizational framework and has the authority and MBS Coordinator assists in program development, managing resources to fulfill all the duties as outlined above. the accreditation process, ensuring continuous compliance • Provides documentation of meeting minutes showing with MBSAQIP Standards, maintaining relevant pathways that the MBS Coordinator has attended at least the and protocols, patient education, monitoring outcomes data minimum number of required MBS Committee and collection, quality improvement initiatives, and the meetings as outlined above. education of relevant staff with a focus on metabolic and • Provides documentation that the MBS Coordinator is a bariatric patient safety. The MBS Coordinator supports the licensed or registered health care professional.* development of written protocols and education of nursing • MBS Coordinator is present and actively participates in staff detailing the rapid communication and basic response each MBSAQIP site visit for their current center(s). to critical patient findings that are specifically required to minimize delays in the diagnosis and treatment of serious *The requirement for the MBS Coordinator to be a licensed adverse events. or registered health care professional applies to individuals hired into the role of MBS Coordinator on or after May 1, The MBS Coordinator serves as the liaison between the 2015. All non-licensed MBS Coordinators hired into the role of facility and all metabolic and bariatric proceduralists at the MBS Coordinator prior to May 1, 2015 are exempt from this center and any general surgeons providing call coverage. The requirement. MBS Coordinator assists in maintaining the documentation of the call schedule provided by all covering surgeons, as well as providing access to the call schedule to all departments of the facility that provide care for metabolic and bariatric patients.

If the MBS Coordinator and MBS Clinical Reviewer are separate individuals, they must work closely together to ensure timely submission of outcomes data to the MBSAQIP Registry.

The center’s organizational framework must incorporate the MBS Coordinator position. The MBS Coordinator must have a job description or contract documenting the authority and resources to fulfill the above listed duties.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 15 Standard 2 | Program Scope and Governance

2.7 Metabolic and Bariatric Surgery (MBS) Clinical Reviewer

MBS Clinical Reviewer Access to Systems and Definition and Requirements Records Requirements In addition to MBSAQIP Registry access, it is required that Timely and accurate data entry is essential for quality the MBS Clinical Reviewer have open and unrestricted access improvement and monitoring of patient safety. Each to electronic and/or paper medical records for all patient- center is required to establish a MBS Clinical Reviewer to related data from the center and physicians’ offices. If enter data into the MBSAQIP Registry. Designated MBS participating metabolic and bariatric surgeon(s) and any Clinical Reviewers are not approved to provide direct associated practice(s) do not provide the MBS Clinical patient care. The MBS Clinical Reviewer is required to Reviewer unrestricted access to all patient-related data, the fulfill case abstraction duties, complete ongoing training center will be in violation of this Standard. The center is and recertification requirements, retrieve and enter long- required to immediately notify the MBSAQIP if any term follow-up data on all patients, and fulfill requests for personnel at the center are no longer authorized to have outcomes data and reports from the MBS Committee and access to the MBSAQIP Registry. other appropriate personnel. If a center loses or changes its MBS Clinical Reviewer for any reason, the center must notify MBS Clinical Reviewer Workspace and the MBSAQIP within 30 days. In this event, the center must Equipment Requirements establish a new MBS Clinical Reviewer. Ensuring the confidentiality of protected health information is imperative while the MBS Clinical Reviewer engages in the During the initial stages of a center’s participation in data abstraction process. It is essential to provide the MBS MBSAQIP, it is acceptable for the MBS Clinical Reviewer Clinical Reviewer with an appropriate workspace to protect to take on limited additional administrative duties (that patient confidentiality. do not involve direct patient care) as long as all of their responsibilities as MBS Clinical Reviewer are fulfilled Requirements for Timely Data Entry and given the highest priority. The number of Full Time Data entry to the MBSAQIP Registry is time sensitive, Equivalents (FTEs) needed to fulfill all required MBS and it is the responsibility of the MBS Clinical Reviewer to Clinical Reviewer duties must be commensurate with the ensure that procedure and follow-up data are entered into center’s annual case volume and follow-up census. Please see the MBSAQIP Registry within the prescribed data entry the MBSAQIP website facs.org/quality-programs/mbsaqip/ timeframes (as defined by MBS Clinical Reviewer training resources for further information regarding the MBS Clinical and the MBSAQIP Registry Operations Manual) to optimize Reviewer role. data entry.

The MBS Clinical Reviewer must be provided with the MBS Clinical Reviewer Participation and Integration appropriate resources and access to data and information The MBS Clinical Reviewer must work closely with both systems at both the center and the physicians’ offices. The clinical and administrative staff and must participate in at MBS Clinical Reviewer must work closely with the center least two MBS Committee meetings annually, one of which and clinicians to ensure that appropriate short term and long- must be the annual comprehensive review meeting. term data elements are available in the medical records. The center’s organizational framework must incorporate the Training and Maintenance of MBS Clinical MBS Clinical Reviewer position. The MBS Clinical Reviewer Reviewer Certification must have a job description or contract documenting the The MBS Clinical Reviewer must be an individual with authority and resources to fulfill the above listed duties. appropriate clinical knowledge and expertise to collect the required data. A sample job description for the MBS The MBS Clinical Reviewer must be present and actively Clinical Reviewer role is available on the MBSAQIP website. participate in each MBSAQIP site visit for their current Satisfactory completion of online initial training, as well as center(s). ongoing maintenance of certification, is required of the MBS Clinical Reviewer. Maintenance of certification as a MBS Clinical Reviewer is based upon participation in ongoing educational webinars, satisfactory completion of a yearly certification exam, as well as compliance with MBSAQIP data integrity audits when necessary.

16 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

Outsourced MBS Clinical Reviewers MBSAQIP allows accredited centers to outsource the MBS Clinical Reviewer role. Outsourced MBS Clinical Reviewers are not directly employed by the center, its physicians, or associated practices, but must still fulfill all of the requirements outlined above, including open and unrestricted access to medical records and participation in the required MBS Committee meetings. Outsourced MBS Clinical Reviewers must also be present and actively participate in each MBSAQIP site visit for their current center(s).

Documentation

• Maintenance of certification for the MBS Clinical Reviewer. • A job description or contract for the MBS Clinical Reviewer position. • MBS Committee meeting minutes documenting participation by the MBS Clinical Reviewer.

Measure of Compliance

• Provides documentation of maintenance of MBS Clinical Reviewer certification as verified by MBSAQIP. • Provides a job description or contract documenting that the MBS Clinical Reviewer position is fully integrated into the organizational framework and has the authority and resources to fulfill all the duties outlined above, including timely data entry to the MBSAQIP Registry with full and unrestricted access to medical records. • Provides documentation of the MBS Committee meeting minutes proving that the MBS Clinical Reviewer has participated in at least two meetings annually, one of which must be the annual comprehensive review meeting. • MBS Clinical Reviewer is present and actively participates in each MBSAQIP site visit for their current center(s).

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 17 Standard 2 | Program Scope and Governance

2.8 Obesity Medicine Director (OMD)

8. The institution’s organizational framework must Definition and Requirements incorporate the OMD position. The OMD must have a job description, contract, or agreement that provides MBSAQIP Obesity Medicine Qualifications are separate the authority and resources to fulfill the duties listed and distinct from surgical and procedural accreditation. above. Only MBSAQIP Comprehensive Centers and MBSAQIP 9. The OMD must be an actively participating member Comprehensive Centers with Adolescent Qualifications are of the MBS Committee and attend, at a minimum, the eligible to seek MBSAQIP Obesity Medicine Qualifications. annual comprehensive review meeting. Centers seeking Obesity Medicine Qualifications must 10. The OMD must be present and actively participate in establish the position of the Obesity Medicine Director each MBSAQIP site visit for their current center(s). (OMD).

The Obesity Medicine Director (OMD) must be a physician Documentation who actively practices in the field of obesity medicine and is credentialed to practice medicine at the center. The OMD • OMD’s credentials to practice medicine at the center. must also organize, integrate, and lead all obesity medicine • MBS Committee meeting minutes documenting services provided at the center. A single individual must fill participation by the OMD. the position of the OMD. Optimal care of obesity medicine • A job description, contract, or agreement for the OMD patients is enhanced by specialized training, education, and position. experience, which may include certification as a Diplomate of the American Board of Obesity Medicine (ABOM®). However, such certifications are not a requirement for Measure of Compliance Standards compliance for the OMD. • Provides documentation of the OMD’s credentials to The center’s MBS Director is eligible to fill the role of the practice medicine at the center. OMD, provided they meet all the requirements enumerated • Provides documentation that the OMD attends, at a here and in Standard 2.5. The OMD must work in minimum, the annual comprehensive review meeting of conjunction with the MBS Director, MBS Coordinator and the MBS Committee. MBS Clinical Reviewer as a member of the MBS Committee. • Provides a job description, contract, or agreement for Specific responsibilities of the OMD include: the OMD documenting that the OMD position is fully 1. The OMD is responsible for standardizing and integrated into the institution’s organizational framework integrating obesity medicine patient care. and has the authority and resources to fulfill all duties as 2. The OMD is responsible for the integration of care for outlined in items 1–10 above. obesity medicine patients with other physicians and advanced practice providers at the center. 3. The OMD is responsible for determining the patient selection criteria for obesity medicine treatment. 4. The OMD is responsible for the development and review of care pathways for obesity medicine patients, as outlined in Standard 5.6. 5. The OMD is responsible for maintaining data collection and outcomes monitoring for obesity medicine patients as outlined in Standard 6.4. 6. The OMD is responsible for the development of quality standards and the evaluation of obesity medicine outcomes for patients with obesity. 7. The OMD is responsible for overseeing the process by which emerging medications and treatment options will be safely introduced to the center with adequate patient protection and oversight (including Institutional Review Board [IRB] approval or IRB exemption when indicated).

18 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Program Scope and Governance | Standard 2

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 19 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 3 Facilities and Equipment Resources Rationale The center must maintain appropriate facilities and equipment for the care of metabolic and bariatric patients. This includes furniture, wheelchairs, operating room tables, appropriately weight-rated or reinforced toilets, beds, radiology capabilities, surgical instruments, and necessary facility requirements for the safe delivery of care to patients with obesity. Facilities and Equipment Resources | Standard 3

3.1 Health Care Facility Accreditation

Definition and Requirements

Health care facility accreditation ensures that care for metabolic and bariatric patients is provided in a safe environment. The applicant facility must be licensed by the appropriate state licensing authority, if required by state law, and/or by one of the following: • The Joint Commission (TJC) • State Health Department • Det Norske Veritas (DNV) • American Osteopathic Association (AOA) • Healthcare Facilities Accreditation Program (HFAP) • American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) • Accreditation Association for Ambulatory Health Care (AAAHC) • Institute for Medical Quality (IMQ) • Center for Improvement in Healthcare Quality (CIHQ)

A comprehensive list of qualifying health care facility accreditations that meet the measure of compliance for this Standard will be updated and maintained as needed on the MBSAQIP website, facs.org/quality-programs/mbsaqip/ resources.

Documentation

• Health care facility accreditation certificate or documentation.

Measure of Compliance

• Provides documentation of the health care facility accreditation certificate or letter from an accrediting agency demonstrating current accreditation status.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 23 Standard 3 | Facilities and Equipment Resources

3.2 Facilities, Equipment, and Furniture

MBSAQIP requires facilities to have a full line of equipment Definition and Requirements and furniture for the care of metabolic and bariatric patients. This includes, but is not limited to, the following equipment The center must have facilities, equipment, and furniture to that must accommodate patients with obesity: accommodate all prospective metabolic and bariatric patients • Examination tables who are within the weight limits of the patient selection • Operating room tables criteria established by the MBS Committee. • Radiology equipment • Fluoroscopy equipment A written or electronic system to ensure that weight- • Medical imaging equipment appropriate equipment is available and used for all metabolic • Surgical instruments (staplers, retractors, long and bariatric patients is required. Staff must be aware of instruments, etc.) the weight capacities and locations of equipment used for • Intensive care unit (ICU) equipment metabolic and bariatric patients. Equipment weight capacities • Crash carts must be documented using the manufacturer’s specifications, • Blood pressure cuffs and this information must be readily available to relevant • Sequential compression devices staff. Stickers and/or labels may be used to identify the weight • Scales capacity of bariatric equipment and furniture, but are not a • Gowns requirement for compliance with this Standard. • Wheelchairs • Walkers The center must also have a rental or lease agreement for any necessary equipment that is not available on-site. This The facility must also have the following amenities to agreement must indicate a guaranteed delivery timeframe accommodate patients with obesity: for the unavailable equipment. The delivery timeframe is • Chairs established at the discretion of the facility. A rental or lease • Beds agreement is not required if all necessary equipment is • Doorways available at the facility. • Showers • Weight-rated or supported toilets*† Centers do not need to have weight appropriate equipment a. Weight-rated floor mounted and furniture in every area of the facility. The requirements b. Weight-rated wall mounted of this Standard only apply to those areas of the facility where c. Supported floor mounted metabolic and bariatric patients receive care. These areas d. Supported wall mounted include, but are not limited to: operating rooms, emergency department, radiology suite, endoscopy suite, intensive care *Toilets must be weight rated or supported to accommodate all unit, designated metabolic and bariatric surgery unit, and prospective metabolic and bariatric patients who fall within the all associated waiting areas where metabolic and bariatric weight limits of the patient selection criteria established by the patients receive care. MBS Committee.

Appropriate patient mobilization and transfer systems must †Bedside commodes can be made available for patients with also be located wherever metabolic and bariatric patients obesity, but cannot be used as a replacement for weight- receive care. Staff must be trained to use this equipment and appropriate toilets. capable of mobilizing patients without injury to themselves or the patient (see Standard 4.4 regarding staff education on MBSAQIP does not specify minimum physical dimensions patient mobilization and transfer). for doorways, hallways, patient rooms, bathrooms, shower rooms, or other such areas of the facility. However, these areas must be able to accommodate all prospective metabolic and bariatric patients who are within the weight limits of the patient selection criteria established by the MBS Committee.

24 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Facilities and Equipment Resources | Standard 3

The center’s patient selection criteria for metabolic and bariatric surgery must take into account the weight limits of existing equipment. The center must document a care pathway for patients that exceed equipment weight limits. This care pathway must specifically address how the center manages and/or refers care for patients presenting to the metabolic and bariatric surgery program who exceed the weight limits of existing equipment and/or patient selection criteria. The exact details of care management and/or patient referral outlined by the pathway are at the discretion of the MBS Committee. The care pathway does not need to address all patients that exceed the weight limits of existing equipment who present to the facility for general medical or surgical care. The care pathway is only required to address patients presenting for metabolic and bariatric care.

Documentation

• Weight appropriate facilities, equipment, and furniture. • A written or electronic system for clearly defining the weight limits of equipment and furniture. • Rental or lease agreement for equipment that is not available on-site. • Care pathway for patients who exceed equipment weight limits.

Measure of Compliance

• Provides proof that weight appropriate facilities, equipment, and furniture are provided in the areas where metabolic and bariatric patients receive care. • Provides documentation of a written or electronic system defining the weight limits of equipment and furniture. • Provides documentation of a rental or lease agreement for equipment and furniture that is not available on-site that indicates a guaranteed delivery timeframe. This is not required for centers that have all required equipment on-site. • Provides documentation of a care pathway for patients who exceed equipment weight limits.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 25 Standard 3 | Facilities and Equipment Resources

3.3 Designated Bariatric Unit

Definition and Requirements

There must be a designated area in the facility for metabolic and bariatric patients where care is provided in a safe environment. The facility must have a dedicated metabolic and bariatric surgery unit or designated cluster of beds maintained in a consistent area of the facility.

Documentation

• Designated bariatric unit or cluster of beds.

Measure of Compliance

• Provides proof that a designated area in the facility exists for the care of metabolic and bariatric patients, with a dedicated metabolic and bariatric surgery unit or designated cluster of beds in a consistent area of the facility.

26 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Facilities and Equipment Resources | Standard 3

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 27 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 4 Personnel and Services Resources Rationale If metabolic and bariatric patients require critical care services, centers and their associated surgeons must ensure that patients receive appropriate care. The facility must maintain various on-site and consultative services required for the care of metabolic and bariatric patients, including the immediate on-site availability of personnel capable of administering advanced cardiovascular life support. Consultants must be available within the specified time as determined by institutional policy.

The responsibility is upon the center, the metabolic and bariatric surgeon, and—ultimately—the MBS Committee and MBS Director, to appropriately select patients and develop selection criteria for the center relative to the center’s available resources and experience. For example, patients who are at risk for specific and predictable complications (renal failure, airway compromise, heart failure, etc.) must be managed in a facility where access to all reasonable medical subspecialty care is available.

All MBSAQIP Comprehensive Center designations must be able to provide CCU and/or ICU services, endoscopy services, and diagnostic and interventional radiology services on-site (additional specialty services outlined in Standard 4.12 may be provided through a transfer agreement). Centers accredited under all other designation levels are eligible to provide these services either on-site or through a transfer agreement. Personnel and Services Resources | Standard 4

4.1 Credentialing Guidelines for Metabolic and Bariatric Surgeons

and adhere to its Standards by implementing changes Definition and Requirements in practice in accordance with feedback from the MBSAQIP or an equivalent regional or national quality The center must have at least one actively practicing improvement program. and credentialed metabolic and bariatric surgeon. The institution’s credentialing body must adhere to current Guidelines for Surgeons with Limited or No Experience in nationally recognized credentialing guidelines for metabolic Bariatric Surgery or Advanced Laparoscopy and bariatric surgery, which must be separate and distinct 1. Applicant surgeon must complete a structured from general surgery credentialing guidelines. Examples of training curriculum in bariatric surgery and advanced nationally recognized guidelines include those produced by laparoscopic surgery as reviewed and approved by the the American Society for Metabolic and Bariatric Surgery MBS Director. (ASMBS), the Society of American Gastrointestinal and 2. The applicant surgeon must have completed a general Endoscopic Surgeons (SAGES), the American College surgery residency. of Surgeons (ACS), and the Society for Surgery of the 3. The applicant surgeon’s initial cases must be performed Alimentary Tract (SSAT). These nationally recognized with a co-surgeon who is a fully credentialed bariatric guidelines are summarized below. surgeon. The absolute number of proctored cases is determined by the local credentialing committee. Any credentialed surgeon or proceduralist must adhere to The local credentialing committee may also wish to all patient and procedure selection criteria established by the delineate separate requirements for those procedures MBSAQIP Standards, and locally by the MBS Committee. which require gastrointestinal stapling versus those that do not. Guidelines for Metabolic and Bariatric 4. It is advisable that the first cases be of lower technical Surgeon Credentialing difficulty with lower risk patients as determined by the 1. Completion of an accredited general surgery residency. MBS Director. 2. Certified or eligible to be certified by the American 5. The surgeon must actively participate in the MBSAQIP Board of Surgery or equivalent (American Osteopathic and adhere to its Standards by implementing changes Board of Surgery, Royal College of Physicians and in practice in accordance with feedback from the Surgeons of Canada). Exceptions to the board MBSAQIP or an equivalent regional or national quality certification requirement are allowed on a case-by-case improvement program. basis. 3. State medical licensure in good standing. Types of Procedures 4. Formal didactic training in bariatric surgery, which The following procedures qualify as bariatric procedures includes completion of an accredited bariatric surgery (open or laparoscopic) under these credentialing guidelines: fellowship and/or documentation of previous bariatric 1. Adjustable gastric banding surgery experience. Supporting documentation, 2. Biliopancreatic diversion with duodenal switch including a case log or bariatric surgery training 3. Biliopancreatic diversion without duodenal switch certificate, must be provided to allow the credentialing 4. Roux-en-Y gastric bypass committee to assess the applicant surgeon’s bariatric 5. Sleeve gastrectomy surgery experience. 6. Revisional or conversional bariatric surgery 5. Participation within a structured metabolic and bariatric center that provides or coordinates • Investigational procedures must be performed under comprehensive, multidisciplinary care of metabolic and IRB approval or IRB exemption. bariatric patients. • Local credentialing committees may wish to delineate 6. Commitment to use bariatric surgery clinical pathways. separate requirements for those procedures that require 7. Privileges to perform gastrointestinal surgery. gastrointestinal stapling versus those that do not. 8. Privileges to perform advanced laparoscopic procedures if laparoscopic bariatric surgery privileges are being requested. 9. Privileges to perform endoluminal therapeutic procedures, if endoluminal privileges are being requested. 10. The surgeon must actively participate in the MBSAQIP

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 31 Standard 4 | Personnel and Services Resources

Guidelines for Surgeons and Non-Surgeon Proceduralists Performing Endoluminal Therapeutic Procedures for the Treatment of Metabolic or Obesity-Related Diseases Individuals performing endoluminal therapeutic procedures for the treatment of metabolic or obesity-related diseases must be credentialed under endoscopic privileges that adhere to current nationally recognized guidelines, such as SAGES Granting Privileges for Gastrointestinal Endoscopy. Providers performing endoluminal therapeutic procedures must be credentialed to perform metabolic and bariatric surgery, and if they are not, they must still be an active participant of the MBS Committee.

Guidelines for Maintenance and Renewal of Privileges 1. Privileges to perform bariatric surgery must be renewed commensurate to each center’s credentialing guidelines. 2. Continuous certification by the American Board of Surgery or its equivalent. 3. Continued active participation within a structured bariatric surgery center. Ongoing participation with the MBSAQIP or an equivalent regional or national quality improvement program. 4. The surgeon must demonstrate continued critical assessment of his or her outcomes as determined by the periodic review of outcomes from an acceptable regional or national outcomes registry. 5. The chief of surgery or his or her designee must verify that these criteria have been met.

Documentation

• Metabolic and bariatric surgery privileges for all actively practicing metabolic and bariatric surgeons at the center. • Gastrointestinal endoscopy privileges for all non- surgeons performing metabolic and bariatric procedures at the center. • Metabolic and bariatric surgery credentialing guidelines.

Measure of Compliance

• Provides documentation of the required metabolic and bariatric surgery privileges for all actively practicing metabolic and bariatric surgeons at the center. • Provides documentation of the required gastrointestinal endoscopy privileges for all non-surgeons performing metabolic and bariatric procedures at the center. • Provides documentation to demonstrate compliance with current nationally recognized credentialing guidelines.

32 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.2 MBSAQIP Surgeon Verification

The following criteria must be met to achieve surgeon Definition and Requirements verification: 1. MBSAQIP Participation: The surgeon’s center must MBSAQIP surgeon verification ensures the presence of be in full compliance with all MBSAQIP Standards and experienced and consistent surgical leadership within the actively participate in the MBSAQIP. accredited center at all times. Surgeon verification is only a 2. Quality Meetings: The surgeon must attend at least two component of MBSAQIP Standards compliance. quality meetings annually. a. MBSAQIP defines a quality meeting as any local, The center’s MBS Director must be a MBSAQIP Verified regional, or national meeting where quality Surgeon in order for the center to achieve MBSAQIP initiatives are discussed, allowing the verified Accreditation. Only the MBS Director is required to meet surgeon to bring new ideas and information to an the criteria outlined below for surgeon verification. All accredited center. Quality meetings do not need to other surgeons at the center are eligible, but not required, to be metabolic or bariatric-specific, but must provide seek surgeon verification if they meet the criteria outlined the verified surgeon an opportunity to learn about below. The MBSAQIP will verify the MBS Director and any quality improvement and apply that knowledge to additional surgeons seeking verification at each MBSAQIP their leadership of a MBSAQIP-Accredited center. site visit. All surgeons who meet criteria will receive b. The annual comprehensive review meeting of the documentation from the MBSAQIP stating that they have MBS Committee (discussed in Standard 2.4) is met the qualifications for a “MBSAQIP Verified Surgeon” allowed to count as one of the two required annual as of the date of the site visit. Surgeon verification must quality meetings for surgeons seeking verification. be renewed during every triennial reaccreditation cycle. Only one annual comprehensive review meeting per Surgeons seeking MBSAQIP verification must be present year is allowed to count toward the quality meeting and actively participate in each MBSAQIP site visit for requirement for surgeon verification. All other their current center(s). MBS Committee meetings do not count as quality meetings. If a center loses or changes its MBS Director for any reason, c. Examples of quality meetings include, but are the center must notify the MBSAQIP within 30 days. In not limited to, departmental quality meetings, this event, the center must establish a new MBS Director. institutional quality committee meetings, If necessary, the MBSAQIP will review documentation SAGES, ASMBS State Chapter meetings, ACS submitted by the center to confirm the new MBS Director State Chapter meetings, Obesity Week, ASMBS meets criteria for surgeon verification to ensure continuous Weekend, ACS Quality and Safety Conference, compliance with Standard 4.2. ACS Clinical Congress, and any additional quality based educational programs offered by the ACS or All surgeons, including MBSAQIP Verified Surgeons, must ASMBS. adhere to the designation level of the MBSAQIP-Accredited d. Morbidity and Mortality Conferences (M&Ms) and center where they are providing care and follow all patient similar peer review meetings do not count as quality and procedure selection criteria established for that meetings. designation level by the MBSAQIP Standards. Surgeons must 3. Lifetime Volume Documentation: The surgeon must also adhere to all patient and procedure selection criteria present a case log to document a minimum of 100 established by the MBS Committee. lifetime stapling procedures. a. The surgeon can count up to 75 stapling procedures The annual volume documentation for surgeon verification from an accredited fellowship toward the lifetime can be accomplished using the surgeon’s procedure volume volume requirement. These procedures must be from any MBSAQIP-Accredited center. Procedure volume documented by a case log and a letter from the from a center that is in the process of applying but has not fellowship director. yet achieved MBSAQIP Accreditation can also be counted, b. The surgeon must perform a minimum of 25 stapling but is limited to procedure volume from the most recent 12 procedures after fellowship for a total of at least 100 months. lifetime stapling procedures.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 33 Standard 4 | Personnel and Services Resources

4. Annual Volume Documentation: The surgeon must submit a case log from the MBSAQIP Registry verifying Documentation that, at minimum, an average of 25 stapling procedures • The MBS Director and each additional surgeon seeking per year were performed during the triennial verification must document the following: reaccreditation cycle. 1. Participation in the MBSAQIP. a. The annual volume documentation can be 2. Participation in at least two quality meetings annually. accomplished using the surgeon’s procedure volume 3. At least 100 lifetime stapling procedures (or 100 lifetime from any MBSAQIP-Accredited center. Procedure non-stapling procedures for centers not performing volume from a center that is in the process of stapling procedures). applying but has not yet achieved MBSAQIP 4. A minimum average of 25 stapling procedures per Accreditation can also be counted, but is limited to year (or 25 non-stapling procedures, for centers not procedure volume from the most recent 12 months. performing stapling procedures). 5. Board Certification:The surgeon must be board 5. Board certification, or in progress board certification. certified or in the process of becoming board certified 6. A minimum average of 8 metabolic and bariatric- by the American Board of Surgery (or equivalent). specific CME per year. Foreign-trained surgeons are eligible for exemption from the board certification requirement and will be evaluated on an individual basis. Measure of Compliance 6. CME: The surgeon is required to complete, at minimum, an average of 8 metabolic and bariatric- • Provides proof that the MBS Director, and each specificAMA PRA Category 1 CME credit hours per additional surgeon(s) seeking verification, meets the year during the triennial reaccreditation cycle. above criteria for surgeon verification. Only the MBS Director is required to be a verified surgeon. Non-Stapling Verification: If the center is only performing • The MBS Director and each additional surgeon(s) non-stapling procedures for the treatment of metabolic seeking verification must be present and actively or obesity-related diseases, verification will follow all participate in each MBSAQIP site visit for their current of the criteria listed above, except the annual volume center(s). documentation will apply to non-stapling procedures only: an average of 25 non-stapling procedures per year. Non- stapling surgeon verification is a separate and distinct form of surgeon verification.

Adolescent Center Verification: This requirement applies only to children’s hospitals seeking accreditation as a MBSAQIP Adolescent Center. For surgeons seeking verification at an Adolescent Center, verification will follow all of the criteria listed above, except that the annual volume documentation requirement is an average of 15 stapling procedures per year. The annual volume requirements for Adolescent Centers are discussed further in Standard 4.15. Adolescent surgeon verification is a separate and distinct form of surgeon verification.

34 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.3 Metabolic and Bariatric Surgery Call Coverage

Surgeons covering call for the center must be available for Definition and Requirements discussion or consultation for patients with a prior history of metabolic and bariatric surgery, inclusive of patients who It is the responsibility of MBSAQIP-Accredited centers are unaffiliated with or unassigned to the applicant center. to provide call coverage for all metabolic and bariatric A protocol that has been endorsed by the MBS Committee patients presenting to the facility, whether or not the center must address the care of unassigned or unaffiliated metabolic performed the patient’s principal metabolic and bariatric and bariatric patients presenting to the applicant center. procedure(s). Call coverage must be provided twenty-four hours a day and 365 days per year. All surgeons performing metabolic and bariatric surgery at the center must have Documentation qualified call coverage at all times by a colleague who is responsible for the emergency care of metabolic and bariatric • Call schedule for at least the past three months. patients in the absence of the primary surgeon. This must • Roster of surgeons who provide metabolic and bariatric include call coverage for the full range of complications surgery call coverage. associated with metabolic and bariatric surgery. All • General surgery privileges for each surgeon. surgeons providing call coverage must be available within • Education of general surgeons who provide metabolic the timeframe determined by institutional policy. It is and bariatric surgery call coverage. the responsibility of the MBS Committee to ensure that • Protocol outlining the care of unassigned or unaffiliated continuous call coverage is provided. The call coverage patients. schedule must be documented and available to all relevant staff. Measure of Compliance Transfer agreements can be used to help facilitate full call coverage, but accredited centers cannot use transfer • Provides documentation of the metabolic and bariatric agreements as a substitute for a call schedule. Furthermore, surgery call schedule for at least the past three months. it cannot be regular practice or a matter of policy to utilize • Provides documentation of the roster of surgeons who transfer agreements as a substitute for managing metabolic provide metabolic and bariatric surgery call coverage and bariatric patients otherwise unaffiliated with, or with documentation of general surgery privileges for unassigned to, the applicant center. each surgeon. • Provides proof of education of general surgeons who If the center’s call coverage involves one or more general provide metabolic and bariatric surgery call coverage in surgeons who are not privileged to perform metabolic and alignment with the education requirements as outlined bariatric surgery, then the general surgeon(s) covering call above. must be credentialed with general surgery privileges and • Provides documentation of a protocol outlining the care must have undergone adequate education and training as of unassigned or unaffiliated metabolic and bariatric determined by the center’s MBS Committee, which must patients presenting to the applicant center. include, at minimum, formal training regarding a basic understanding of: • Metabolic and bariatric procedures commonly performed at the center • Signs and symptoms of postoperative complications • Management and care of patients by a review of the center’s clinical pathways and protocols

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 35 Standard 4 | Personnel and Services Resources

4.4 Staff Training

Training Level 3 Definition and Requirements Course Name: Signs and Symptoms of Postoperative There must be well-established, properly managed, and Complications ongoing education programs for the metabolic and bariatric team and all relevant staff. The educational programs must Course Description: Education must ensure that those ensure a basic understanding of metabolic and bariatric caring for metabolic and bariatric patients are able to surgery and patient care, including the risks and benefits for recognize the potential signs and symptoms of common all procedures performed at the center and the appropriate metabolic and bariatric surgery complications (for example, management and care of metabolic and bariatric patients. pulmonary embolus, anastomotic leak, infection, bowel obstruction, etc.) to ensure that patients can be managed All appropriate personnel caring for metabolic and bariatric appropriately. patients are required to complete the following training sessions: Required Staff: All licensed health care providers who have direct contact with metabolic and bariatric patients. Training Level 1 Minimum Frequency: At initial hire and annually thereafter. Course Name: Sensitivity Training

Course Description: Education must support a culture Documentation where all staff members are prepared to manage patients with obesity, (whether or not metabolic and bariatric surgery • Documentation of staff training. is the indication for medical care), with the understanding and compassion to appreciate the burdens of patients with obesity. Measure of Compliance

Required Staff: All staff and licensed health care providers • Provides documentation that educational training is that have, or potentially have, direct contact with metabolic provided to relevant staff as outlined above. and bariatric patients.

Minimum Frequency: At initial hire and repeated within each triennial reaccreditation cycle.

Training Level 2

Course Name: Patient Transfer and Mobilization

Course Description: Education must address the safe transfer and mobilization of patients with obesity, to protect the safety of both patients and staff. This training is also beneficial when providing care for the increasing number of patients with obesity who present for other types of medical care.

Required Staff: All staff and licensed health care providers who may need to mobilize or transfer metabolic and bariatric patients.

Minimum Frequency: At initial hire and repeated within each triennial reaccreditation cycle.

36 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.5 Multidisciplinary Team

Definition and Requirements

The center must establish a multidisciplinary team capable of providing an integrated health approach to metabolic and bariatric patients. Optimal care of metabolic and bariatric patients requires specialized training, education, and experience, which may include Certified Bariatric Nurse (CBN®) certification. The center must provide access or referral to the following disciplines, as needed, for preoperative, perioperative, and postoperative care. a. Consistent operating room staff or operating room team b. Registered nurses, advanced practice nurses, or other advanced practice providers c. Registered dietitians d. Psychologists, psychiatrists, social workers, or other licensed behavioral health care providers e. Physical or exercise therapists

If a center is accredited to perform metabolic and bariatric surgery on adolescents, a psychologist, psychiatrist, or other qualified and licensed behavioral health care provider with specific training and credentialing in pediatric and adolescent care must perform the behavioral assessment. This requirement is discussed further in Standard 4.14.

Documentation

• Credentials or certification for the multidisciplinary team members listed above.

Measure of Compliance

• Provides documentation of a multidisciplinary, integrated health team for metabolic and bariatric patients, as outlined above.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 37 Standard 4 | Personnel and Services Resources

4.6 Advanced Cardiovascular Life Support (ACLS)

Definition and Requirements

An ACLS-qualified physician, ACLS-qualified advanced practice provider, or other licensed health care provider who is capable of administering ACLS (including cardiac defibrillation, drug administration, advanced airway management, etc.) must be on-site at all times when metabolic and bariatric patients are present. This requirement ensures that a qualified provider is available to perform patient resuscitations at any time when anesthesia is not being administered. Centers with an emergency department can fulfill this requirement with a credentialed emergency department physician, as long as hospital policy dictates that such a physician is available at all times.

Documentation

• Credentials for an ACLS-qualified licensed health care provider who is on-site at the facility at all times.

Measure of Compliance

• Provides documentation that an ACLS-qualified physician, advanced practice provider, credentialed emergency department physician, or other licensed health care provider who is capable of administering ACLS, as well as advanced airway management, is on-site at the facility at all times when metabolic and bariatric patients are present.

38 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.7 Patient Stabilization

Definition and Requirements

All MBSAQIP-Accredited centers must have the ability to stabilize critically ill metabolic and bariatric patients. The facility must have the ability to intubate and manage a difficult airway, and ventilators and hemodynamic monitoring equipment must be immediately available.

If the center is unable to manage the patient on-site, the center must have the ability to stabilize a critically ill metabolic and bariatric patient until the patient can be transferred to a higher level of care (see Standard 5.3 regarding written transfer agreements).

Documentation

• Difficult airway cart, ventilator, and hemodynamic monitoring equipment available onsite.

Measure of Compliance

• Provides proof of the ability to stabilize critically ill metabolic and bariatric patients by providing physical proof of a difficult airway cart, ventilator, and hemodynamic monitoring equipment.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 39 Standard 4 | Personnel and Services Resources

4.8 Critical Care Unit (CCU) / Intensive Care Unit (ICU) Services

Definition and Requirements

CCU/ICU requirements: 1. CCU/ICU equipment that accommodates patients with obesity. 2. Physician, surgeon, or intensivist who has met credentialing criteria by the facility to manage critically ill patients, who must be available twenty-four hours a day and 365 days per year. a. If a physician, surgeon, or intensivist is not available, an off-site CCU/ICU monitoring system is acceptable only if the center has all of the other critical care requirements in Standards 4.6-4.12 available on-site. 3. Trained critical care nurses who have met the center’s credentialing criteria must be available twenty-four hours a day and 365 days per year. 4. All MBSAQIP Comprehensive Center designations must have critical care unit capability on-site. Centers seeking all other designation levels (Low Acuity, Ambulatory, and Adolescent Centers) that do not have critical care unit capability on-site must have a signed written transfer agreement that details the transfer plan of metabolic and bariatric patients to another facility that fully meets all the above requirements.

Documentation

• CCU/ICU services available on-site. • Credentials for at least one physician, surgeon, or intensivist approved to manage critically-ill patients. • Job description and licensure for at least one credentialed critical care nurse.

Measure of Compliance

• Provides proof of access to critical care services that meet the above requirements. • Provides documentation of credentials for a physician, surgeon, or intensivist approved to manage critically-ill patients. • Provides documentation of a job description and licensure for at least one credentialed critical care nurse.

40 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.9 Anesthesia Services

Definition and Requirements

Anesthesiology requirements for perioperative management of metabolic and bariatric patients:

Anesthesia providers must be approved by the center’s credentialing body. Anesthesia providers must also adhere to local and state laws governing their scope of practice.

Accredited centers must have an anesthesia protocol specific to the care of metabolic and bariatric patients that is approved by the MBS Committee. A general surgery anesthesia protocol alone is not sufficient to meet the measure of compliance for this Standard. The metabolic and bariatric anesthesia protocol must address the following, at a minimum: 1. Basic guidelines for the anesthesia management of metabolic and bariatric patients 2. Hemodynamic monitoring 3. Fluid intake and management 4. Mobilization and positioning of patients with obesity while under sedation 5. Difficult airway management

Documentation

• Anesthesia protocol specific to the care of metabolic and bariatric patients. • Credentials for at least one approved anesthesia provider.

Measure of Compliance

• Provides documentation of an anesthesia protocol specific to metabolic and bariatric patients, which is approved by the MBS Committee, as outlined above. • Provides documentation of the credentials for anesthesia providers who care for metabolic and bariatric patients that adhere to local and state laws governing their scope of practice.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 41 Standard 4 | Personnel and Services Resources

4.10 Endoscopy Services

Definition and Requirements

Endoscopy services requirements: 1. Physician who has met credentialing criteria by the center to perform diagnostic and therapeutic endoscopy. 2. Trained nursing staff responsible for assisting endoscopists in performing gastrointestinal (GI) endoscopy. 3. All MBSAQIP Comprehensive Center designations must have endoscopy services on-site. Centers seeking all other designation levels (Low Acuity, Ambulatory, and Adolescent Centers) that do not have endoscopy capability on-site must have a signed written transfer agreement that details the transfer plan of metabolic and bariatric patients to another facility that fully meets all the above requirements.

Documentation

• Endoscopy services available on-site. • Credentials for at least one physician approved to provide endoscopy services.

Measure of Compliance

• Provides proof of access to endoscopy services that meet the above requirements. • Provides documentation of credentials for at least one physician approved to perform diagnostic and therapeutic endoscopy as outlined above.

42 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.11 Diagnostic and Interventional Radiology Services

Definition and Requirements

Diagnostic and interventional radiology services requirements: 1. A physician who meets credentialing criteria by the facility to perform imaging, percutaneous drainage, and other radiology procedures. a. A fully equipped interventional radiology suite is not required for compliance with this Standard. The center’s interventional radiology services must be able to perform basic interventional procedures on site. Basic equipment and associated capabilities may include, but are not limited to: i. Computed tomography (CT) ii. Fluoroscopy iii. Ultrasound 2. All MBSAQIP Comprehensive Center designations must have diagnostic and interventional radiology services onsite. Centers seeking all other designation levels (Low Acuity, Ambulatory, and Adolescent Centers) that do not have interventional radiology capability on-site must have a signed written transfer agreement that details the transfer plan of metabolic and bariatric patients to another facility that fully meets all the above requirements.

Documentation

• Diagnostic and interventional radiology services available on-site. • Credentials for at least one physician approved to provide radiology services.

Measure of Compliance

• Provides proof of access to diagnostic and interventional radiology services that meet the above requirements. • Provides documentation of credentials for at least one physician approved to perform diagnostic and interventional radiology services as outlined above.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 43 Standard 4 | Personnel and Services Resources

4.12 Specialty Services

Definition and Requirements

Accredited centers must have available for consultation, twenty-four hours a day and 365 days per year, credentialed consultants capable of managing the full range of metabolic and bariatric surgery complications: 1. Pulmonology and/or critical care 2. Cardiology 3. Nephrology

All centers must have the above specialty services available on-site or must have a signed written transfer agreement that details the transfer plan for metabolic and bariatric patients to another facility that can provide the specialty services listed above.

Documentation

• Credentials for the consultants for all additional specialty services. • A written transfer agreement for any specialty service listed above that is not provided on-site.

Measure of Compliance

• Provides documentation of credentials for at least one physician who provides consultative coverage for each of the additional specialty services listed above. • Provides proof of access to all the additional specialty services listed above twenty-four hours a day and 365 days per year. • Provides documentation of a signed, written transfer agreement for any specialty service listed above that is not provided on-site.

44 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.13 Pediatric Medical Advisor (PMA)

The responsibilities of the PMA are to provide documented Definition and Requirements ongoing general pediatric medical oversight in addition to assisting in the utilization of adolescent-specific sub-specialty MBSAQIP Adolescent Centers and Comprehensive Centers consultations when needed (for example: sleep medicine, with Adolescent Qualifications must establish a Pediatric gastroenterology, endocrinology, hematology, nephrology, Medical Advisor (PMA). The PMA must be a member of the behavioral health, etc.). Additionally, the PMA must assist MBS Committee (as outlined in Standard 2.4). in the development of comorbid-specific treatment plans in conjunction with the patient’s primary care provider in order Pediatric Medical Advisor (PMA) to optimize perioperative health. At minimum, the PMA Every adolescent patient requires a pediatrician or equivalent must attend the annual comprehensive review meeting of the provider who participates in their preoperative and MBS Committee and any MBS Committee meeting where postoperative care. All MBSAQIP-Accredited centers that pediatric patients are discussed. provide care for adolescent metabolic and bariatric patients must establish a PMA, and the PMA must be a member of The Pediatric Medical Advisor must be present and actively the MBS Committee. participate in each MBSAQIP site visit for their current center(s). In MBSAQIP Adolescent Centers, the PMA must fit one of the following physician descriptions: • A physician with educational training who is Documentation credentialed in general pediatrics and/or pediatric sub-specialty training (for example, endocrinology, • A qualified PMA must be established. cardiology, gastroenterology, adolescent medicine, etc.). • Privileges and credentials of the PMA. • An internal medicine physician or family practitioner • MBS Committee meeting minutes documenting with specific training and experience in adolescent participation by the PMA. medicine.

A pediatric surgeon is not eligible to serve as the center’s Measure of Compliance PMA. • Provides proof that the center has identified an In MBSAQIP Comprehensive Centers with Adolescent individual to serve as the PMA who meets the Qualifications, the PMA must fit one of the following qualifications outlined above. physician descriptions: • Provides documentation of the privileges and credentials • A physician with educational training who is of the PMA. credentialed in general pediatrics and/or pediatric • Provides documentation that the PMA attended sub-specialty training (for example, endocrinology, the annual comprehensive review meeting and any cardiology, gastroenterology, adolescent medicine, etc.). additional MBS Committee meeting where pediatric • An internal medicine physician or family practitioner patients were discussed. with specific training and experience in adolescent • The PMA is present and actively participates in each medicine. MBSAQIP site visit for their current center(s). • If no qualifying individual exists in a Comprehensive Center with Adolescent Qualifications, a specific individual who meets the training qualifications outlined above must be identified within the local medical community to serve as the PMA.

A pediatric surgeon is not eligible to serve as the center’s PMA.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 45 Standard 4 | Personnel and Services Resources

4.14 Pediatric Behavioral Specialist

Definition and Requirements Documentation

MBSAQIP Adolescent Centers and Comprehensive Centers • A qualified pediatric behavioral specialist with with Adolescent Qualifications must provide access to a experience. pediatric behavioral specialist for all adolescent patients. • Privileges and credentials of the pediatric behavioral specialist. The adolescent patient and their family must be able to demonstrate awareness of the general risks and benefits of metabolic and bariatric surgery as well as awareness of Measure of Compliance the dietary and physical activity requirements following a metabolic and bariatric procedure. A psychologist, • Provides documentation that the center has identified an psychiatrist, or other qualified and licensed behavioral health individual to serve as the pediatric behavioral specialist care provider with specific training and credentialing in who meets the qualifications outlined above. pediatric or adolescent care must perform this assessment. • Provides documentation of the privileges and credentials The pediatric behavioral specialist must have experience in of the pediatric behavioral specialist. treating obesity and eating disorders as well as experience evaluating adolescent patients and their families. If a qualified pediatric behavioral specialist is not present in a MBSAQIP- Accredited center that provides care for adolescent metabolic and bariatric patients, a specific individual with the aforementioned training must be identified by the MBS Committee. Evaluation by a pediatric behavioral specialist is critical to ensuring that full assent to the proposed care plan can be obtained.

Documentation of the following behavioral assessment elements must be obtained in order to consider an adolescent patient for any metabolic and bariatric procedure: • Evidence for mature decision making and awareness of potential risks and benefits of the proposed procedure. • Documentation of the adolescent’s ability to provide surgical assent. • Evidence of appropriate family and social support mechanisms (engaged and supportive family members, care takers, etc.). • If behavioral disorders are present (depression, anxiety, etc.), there must be evidence that these conditions have been satisfactorily treated.

Evidence must be provided that the family and patient have the ability and motivation to comply with recommended treatments preoperatively and postoperatively, including consistent use of recommended nutritional supplements. Evidence may include a history of reliable attendance at office visits for weight management and compliance with other medical care plans.

46 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Personnel and Services Resources | Standard 4

4.15 Children’s Hospital Service Requirements

Definition and Requirements Measure of Compliance

This Standard applies only to children’s hospitals performing • Provides documentation of a minimum of 15 stapling metabolic and bariatric procedures. A children’s hospital can procedures annually to meet the volume requirement only be accredited as a MBSAQIP Adolescent Center. for a MBSAQIP Adolescent Center. Volume data will be verified with a case log and by chart review during the Recognizing that adolescent volume is more difficult to site visit. achieve due to a number of unique factors, the volume • Provides documentation of the co-surgeon’s credentials requirements for Adolescent Centers (outlined in Standard at a facility with a MBSAQIP Comprehensive Center 2.1) must be met in one of the following ways: designation, if a co-surgeon is required as outlined 1. Adolescent Centers performing a minimum of 15 above. stapling procedures annually will be unrestricted and • Provides documentation that the co-surgeon is a do not require a bariatric co-surgeon. MBSAQIP Verified Surgeon, if a co-surgeon is required 2. Adolescent Centers performing fewer than 15 stapling as outlined above. procedures annually require a bariatric co-surgeon • Provides documentation of the co-surgeon’s presence present for all stapling cases. The co-surgeon must be at required cases, if a co-surgeon is required as outlined a MBSAQIP Verified Surgeon (outlined in Standard above. 4.2) who has credentials at a facility with a MBSAQIP Comprehensive Center designation. The MBS Director or another surgeon at the Adolescent Center can fulfill the co-surgeon requirement if they are verified and credentialed at a facility with a MBSAQIP Comprehensive Center designation. The co-surgeon is not required to be present for non-stapling bariatric procedures performed on adolescent patients.

Documentation

• Case log documenting at least 15 stapling procedures annually. • If applicable, the credentials of the co-surgeon. • If applicable, proof the co-surgeon is a MBSAQIP Verified Surgeon. • If applicable, case logs documenting the co-surgeon’s presence during required cases.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 47 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 5 Patient Care: Expectations and Protocols Rationale The center must utilize comprehensive clinical pathways that facilitate the standardization of patient care for metabolic and bariatric procedures. Pathways are a sequence of orders and therapies describing the routine care for metabolic and bariatric patients from initial evaluation through long-term follow-up. MBSAQIP requires that patient care pathways are thoroughly documented and followed appropriately by both surgeons and advanced practice providers treating metabolic and bariatric patients. Clinical pathways are allowed to be documented in a variety of formats, including tables, algorithms, process maps, and paragraph form. All staff caring for metabolic and bariatric patients must be aware of the pathways pertinent to their area of practice.

MBSAQIP Obesity Medicine Qualifications provide an additional designation level for facilities that offer non-procedural treatment for patients who are overweight and patients with Class I, II, and III obesity. Centers with Obesity Medicine Qualifications employ therapeutic interventions including nutritional intervention, physical activity, behavioral change, and pharmacotherapy. These centers must utilize a comprehensive approach to providing care for patients with obesity as described in the Obesity Medicine Standards (Standards 2.8, 5.6, and 6.4), including the use of additional specialists such as dietitians, exercise specialists, behavioral health professionals, obesity medicine specialists, advanced practice providers, and bariatric surgeons to achieve optimal results. Additionally, obesity medicine practitioners function as an effective resource for providing both pre- and post-operative care for metabolic and bariatric patients, while advocating for all patients with obesity. Patient Care: Expectations and Protocols | Standard 5

5.1 Patient Education Pathways

Definition and Requirements

All metabolic and bariatric surgeons or proceduralists at the center must utilize patient education pathways that provide a comprehensive overview of pre- and post-operative care for metabolic and bariatric patients. The patient education pathways for each surgeon or proceduralist must be approved by the center’s MBS Committee. At a minimum, the following patient education pathways are required: 1. Indications and contraindications for metabolic and bariatric procedures. 2. All procedure options provided by the center and the center’s volume specific to each procedure, as well as the expected outcomes of each procedure. There must be a clear explanation of the goals, risks, benefits, and alternatives of each procedure in order to demonstrate an informed consent process. 3. Instructions regarding diet, exercise, vitamin and mineral supplementation, and lifestyle changes. 4. The expected course of the perioperative care must be explained as well as a thorough explanation of discharge instructions that include activities, diet, follow-up appointments, medications, and signs and symptoms of complications such as tachycardia, fever, shortness of breath, excessive abdominal pain, and vomiting.

Documentation

• Patient education pathways for each surgeon or proceduralist.

Measure of Compliance

• Provides documentation of the patient education pathways for each metabolic and bariatric surgeon or proceduralist, which meet the requirements outlined above and have been approved by the MBS Committee.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 51 Standard 5 | Patient Care: Expectations and Protocols

5.2 Patient Care Pathways

Definition and Requirements Measure of Compliance

Each center must utilize patient care pathways outlining • Provides documentation of the patient care pathways for the process for evaluating patients seeking metabolic and each metabolic and bariatric surgeon or proceduralist, bariatric surgery. The pathways must be reviewed regularly inclusion and exclusion patient selection criteria, (annually, at a minimum) by the MBS Committee and revised and evaluation process, including psychological if indicated by the review of the center’s outcomes data. The evaluation, preoperative clearance, nutrition regimens, following pathways are required and must be approved by the and metabolic and bariatric standardized order sets, center’s MBS Committee: addressing all of the requirements outlined above. 1. Defined patient selection criteria based on available • Provides documentation of MBS Committee meeting resources, including equipment weight limits, and the minutes showing, at minimum, annual review of patient expertise of the center care pathways, which indicate any revisions driven by 2. Psychosocial-behavioral evaluation the review of the center’s outcomes data. 3. Algorithms for preoperative system clearance 4. Preoperative and postoperative nutrition regimen

Each practicing metabolic and bariatric surgeon or proceduralist at the center must use a standardized order set, specific to metabolic and bariatric procedures. This order set must address: 1. Dietary progression 2. Deep vein thrombosis prophylaxis 3. Respiratory care 4. Physical activity 5. Pain management 6. Parameters for notifying the attending physician

There must be a defined process for the early recognition and management of warning signs of complications, including tachycardia, fever, shortness of breath, excessive abdominal pain, and vomiting.

Documentation

• Patient care pathways for each surgeon or proceduralist. • Standardized order sets for each surgeon or proceduralist. • MBS Committee meeting minutes documenting annual review of the patient care pathways.

52 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Patient Care: Expectations and Protocols | Standard 5

5.3 Written Transfer Agreement

Definition and Requirements Documentation

MBSAQIP-Accredited centers must be able to reasonably • A signed written transfer agreement, if applicable. recognize and treat patients with metabolic and bariatric surgery complications. Transfer agreements cannot be used as a substitute for the standard and usual care of metabolic Measure of Compliance and bariatric patients. • Provides documentation of a signed written transfer If the center is unable to manage the full range of metabolic agreement that details the transfer plan in place for both and bariatric surgery complications, they must have a signed emergent and non-emergent metabolic and bariatric written transfer agreement that details the transfer plan patients as outlined above, if patient transfer is part of of metabolic and bariatric patients to other emergency or the care pathway. critical care facilities that have the capability of managing the full range of metabolic and bariatric surgery complications. Centers must have the staff and equipment needed to transfer patients with obesity to an inpatient facility capable of providing a higher level of care.

To address metabolic and bariatric patients requiring emergent care, surgeons performing metabolic and bariatric procedures at Low Acuity Centers and Ambulatory Surgery Centers must have admitting privileges or a written transfer agreement as outlined below in this Standard.

To address long-term surgical complications requiring inpatient diagnosis and treatment, but not emergent care, all surgeons performing metabolic and bariatric procedures at Low Acuity Centers and Ambulatory Surgery Centers must have admitting privileges or a written transfer agreement in place with a facility with a MBSAQIP Comprehensive Center designation.

Transfer requirements: 1. A plan for safe transfer of metabolic and bariatric patients requiring emergent care to a full-service facility must be implemented, from the time of the transfer decision to the initiation of care at the accepting facility. 2. A plan for safe transfer of metabolic and bariatric patients requiring non-emergent care to a facility with a MBSAQIP Comprehensive Center designation must be implemented, from the time of the transfer decision to the initiation of care at the accepting facility. 3. Facilities must have adequate staff available to provide emergency support, including the time during transfer, until the receiving facility assumes the patient’s care. 4. An ACLS-certified individual must accompany the patient during the transfer.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 53 Standard 5 | Patient Care: Expectations and Protocols

5.4 Inpatient Admitting Privileges

Definition and Requirements Measure of Compliance

This Standard only applies to outpatient facilities accredited • Provides documentation of inpatient admitting as MBSAQIP Ambulatory Surgery Centers. privileges for all metabolic and bariatric surgeons. • Provides documentation of inpatient admitting To address metabolic and bariatric patients requiring privileges for all metabolic and bariatric surgeons at emergent care, all surgeons performing metabolic and a facility with a MBSAQIP Comprehensive Center bariatric procedures at Ambulatory Surgery Centers must designation. have admitting privileges at an inpatient facility with the • Provides documentation of the transfer process for capability to manage the full range of metabolic and bariatric critically ill or emergent metabolic and bariatric patients, surgery complications. including the signed written transfer agreement.

To address metabolic and bariatric patients requiring non- emergent care, all surgeons performing metabolic and bariatric procedures at Ambulatory Surgery Centers must have admitting privileges at a facility with a MBSAQIP Comprehensive Center designation with the capability to address long-term surgical complications requiring inpatient diagnosis and treatment.

All Ambulatory Surgery Centers must have a signed written transfer agreement that meets all the requirements outlined in Standard 5.3, documenting the transfer process for critically ill or emergent metabolic and bariatric patients. The signed written transfer agreement must also cover the transition of care for non-emergent metabolic and bariatric patients if the requirement for admitting privileges at a facility with a MBSAQIP Comprehensive Center designation cannot be met for any reason.

Documentation

• Inpatient admitting privileges for all bariatric surgeons. • Inpatient admitting privileges at a facility with a MBSAQIP Comprehensive Center designation for all bariatric surgeons. • Signed written transfer agreement.

54 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Patient Care: Expectations and Protocols | Standard 5

5.5 Risk Assessment Protocol

Definition and Requirements

This Standard only applies to outpatient facilities accredited as MBSAQIP Ambulatory Surgery Centers.

Facilities designated as an Ambulatory Surgery Center must adhere to the patient and procedure selection criteria outlined in Standard 2.3.

To further ensure patient safety, Ambulatory Surgery Centers must develop a risk assessment protocol for treating metabolic and bariatric patients in an outpatient setting. The risk assessment protocol must be endorsed by the MBS Committee. The risk assessment protocol must be inclusive of the patient and procedure selection criteria outlined in Standard 2.3, as well as any additional criteria and safety measures that are deemed necessary by the MBS Committee. The members of the MBS Committee must follow the risk assessment protocol for all discussions regarding patient selection in an Ambulatory Surgery Center. Ambulatory Surgery Centers must review the risk assessment protocol once per year, at a minimum, during the annual comprehensive review meeting of the MBS Committee. The center’s compliance with the protocol must also be reviewed annually.

Documentation

• A risk assessment protocol. • MBS Committee meeting minutes documenting a review of the risk assessment protocol and compliance against the risk assessment protocol.

Measure of Compliance

• Provides documentation that a risk assessment protocol has been endorsed by the MBS Committee. • Provides documentation of review of the risk assessment protocol during the annual comprehensive review meeting of the MBS Committee, including a review of the center’s compliance with the risk assessment protocol.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 55 Standard 5 | Patient Care: Expectations and Protocols

5.6 Obesity Medicine Services

Definition and Requirements Documentation

MBSAQIP Obesity Medicine Qualifications are separate • Care pathways for all of the required obesity medicine and distinct from surgical and procedural accreditation. services. Only MBSAQIP Comprehensive Centers and MBSAQIP • MBS Committee meeting minutes documenting annual Comprehensive Centers with Adolescent Qualifications are review of the care pathways. eligible to seek MBSAQIP Obesity Medicine Qualifications. • Education of other physicians and advanced practice providers. MBSAQIP-Accredited centers with Obesity Medicine Qualifications must be able to provide comprehensive, multidisciplinary obesity medicine services. The medical Measure of Compliance treatment of patients with obesity must be implemented using care pathways developed by the Obesity Medicine • Provides documentation of established care pathways for Director (OMD), in conjunction with the MBS Committee. all of the required obesity medicine services listed above. Care pathways for obesity medicine services must be • Provides MBS Committee meeting minutes reviewed annually, at a minimum, by the OMD and the MBS documenting, at minimum, annual review of the obesity Committee. The pathways must be revised when indicated by medicine care pathways, which indicate any revisions emerging research and outcomes data in the field of obesity driven by emerging research and outcomes data in the medicine. field of obesity medicine. • Provides documentation that all other physicians and The center is required to offer all of the following obesity advanced practice providers caring for obesity medicine medicine services utilizing care pathways developed by the patients have undergone education and training in OMD: obesity medicine as outlined above, as directed by the 1. Comprehensive medical examination OMD. 2. Evaluation for medical complications related to obesity 3. Assessment of personal and family history of obesity 4. Laboratory testing 5. Nutrition counseling 6. Fitness and exercise counseling 7. Behavior and lifestyle counseling 8. Anti-obesity medication 9. Evaluation and treatment for abnormal weight gain

When obesity medicine services are provided by other physicians or advanced practice providers within the center, those individuals must work collaboratively with the Obesity Medicine Director (OMD) to coordinate patient care. These individuals must also undergo education and training in obesity medicine, as directed by the OMD, which must include, at minimum: • Obesity medicine treatment options available at the center • Management and care of obesity medicine patients using the center’s care pathways • Anti-obesity medication prescribing practices

Advanced practice providers are allowed to coordinate care for obesity medicine patients, but only under the oversight and supervision of the OMD.

56 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Patient Care: Expectations and Protocols | Standard 5

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 57 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 6 Data Surveillance and Systems Rationale

High-quality data is critical to inform quality improvement and measure the performance of metabolic and bariatric surgery programs.

All metabolic and bariatric procedures performed for the treatment of metabolic or obesity- related diseases must be entered into the MBSAQIP Registry, including those performed by non-metabolic and bariatric surgery credentialed proceduralists and general surgeons.

Data collection is ultimately the responsibility of the MBS Director working collaboratively with the MBS Clinical Reviewer, physician offices, and institutional departments to ensure accurate short and long-term results.

The MBSAQIP Registry collects prospective, risk-adjusted, clinically rich data based on standardized definitions. Data variables to be collected are provided via the MBSAQIP Registry. Data variables are periodically updated, refined, added, or deleted to optimize the information entered into the MBSAQIP Registry while minimizing the data collection burden. Centers have the opportunity to submit and track additional data elements as desired using custom fields within the MBSAQIP Registry.

Data are validated through multiple mechanisms that are continuously updated to optimize the quality of the data collected. The MBSAQIP Registry was developed to minimize the potential to submit inaccurate data and to prevent missing data. Centers are required to intermittently submit administrative or other corroborating data as an audit against the data entered. Data are validated in a systematic fashion as part of MBSAQIP site visits. MBS Clinical Reviewers are trained data reviewers who are not directly involved in patient care. Ongoing training and assessment of the MBS Clinical Reviewer’s processes and knowledge is monitored as another means to validate data entry (see Standard 2.7 for more information). Additional data integrity audits, information, or clarifications may be required by the MBSAQIP.

Data is collected at 30 days, six months, one year, and annually thereafter. Follow-up data is used to assess morbidity and mortality, as well as clinical effectiveness concerning changes in weight and weight-related comorbidities. Risk-adjusted metrics have been developed for quality assessment and improvement. Data Surveillance and Systems | Standard 6

6.1 Data Entry

Data Collection for Emergency Department Visits, Definition and Requirements Readmissions, and Patient Transfers All MBSAQIP-Accredited centers are required to collect Every metabolic and bariatric procedure (open, laparoscopic, necessary data elements in an effort to monitor patient hand-assisted, robotic, or endoscopic) performed for the safety and improve the quality of care provided to metabolic treatment of metabolic or obesity-related diseases must be and bariatric patients. This includes monitoring emergency entered into the MBSAQIP Registry, including: department visits, readmissions, and patient transfers to any • Primary metabolic and bariatric procedures inpatient facility during the 30-day postoperative period. • Reoperations subsequent to a metabolic and bariatric The center must provide a written protocol for how it will procedure (regardless of where the primary metabolic monitor the data entry and patient follow-up associated and bariatric procedure occurred), including: with emergency department visits, readmissions, and –– Non-elective reoperations, revisions and patient transfers to other institutions. This protocol must be conversions performed due to complications endorsed by the MBS Committee. related to a primary metabolic and bariatric procedure –– Elective revisions and conversions performed Documentation subsequent to a primary metabolic and bariatric procedure • A letter of attestation, signed by the MBS Director and • Endoluminal therapeutic procedures for the treatment of MBS Clinical Reviewer, confirming 100 percent data metabolic or obesity-related diseases entry into the MBSAQIP Registry. • Case logs from hospital and/or physician records for all All endoluminal therapeutic procedures for the treatment metabolic and bariatric procedures. of metabolic or obesity-related diseases performed at an • IRB approval or IRB exemption for all primary accredited center must be done with the oversight of the MBS procedures not endorsed by the ASMBS. Director and the MBS Committee, and all such procedures • Written protocol for monitoring emergency department must be entered into the MBSAQIP Registry. visits, readmissions, and patient transfers to other The data from all metabolic and bariatric procedures institutions. performed on patients of any body mass index must be entered into the MBSAQIP Registry. Any primary, revisional, or conversion procedure, whether surgical or non-surgical, Measure of Compliance performed for the treatment of metabolic or obesity-related diseases requires entry into the MBSAQIP Registry. FDA • Provides documentation of a letter of attestation signed preapproval trials are the only exception to this rule. by the MBS Director and the MBS Clinical Reviewer confirming 100 percent data entry into the MBSAQIP The ASMBS publishes a list of endorsed metabolic and Registry as outlined above. bariatric procedures on the ASMBS website, asmbs.org. • Provides documentation of an administrative data file Accredited centers must receive approval from an and/or physician records to verify that 100 percent of Institutional Review Board (IRB) in order to perform metabolic and bariatric procedures are submitted and primary procedures that are not endorsed by the ASMBS. that data do not deviate from the cases entered into the The IRB approval must be for performing the procedures, MBSAQIP Registry. and not solely for data collection of outcomes from these • Provides documentation of IRB approval or IRB procedures. In the event that an Institutional Review Board exemption if the center performs any primary metabolic determines a study protocol unnecessary for a primary and bariatric procedures that are not endorsed by the procedure that is not endorsed by the ASMBS, a letter of ASMBS. exemption from the Institutional Review Board is required. • Provides documentation of a written protocol, endorsed Procedures and devices used for reoperative purposes do by the MBS Committee, for monitoring emergency not require IRB approval or IRB exemption. department visits, readmissions, and patient transfers to other institutions. The MBS Committee is responsible for overseeing the process through which emerging technologies, new procedures, and variations of existing ASMBS-endorsed procedures may be safely introduced at the center, ensuring adequate patient protection, oversight (including IRB approval or IRB exemption when indicated), and outcomes reporting.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 61 Standard 6 | Data Surveillance and Systems

6.2 30-Day and Long-Term Follow-Up

• Physician assistant assessment Definition and Requirements • Clinical nurse specialist with experience, training, or certification in the care of metabolic and bariatric Long-term follow-up is essential to evaluate outcomes of patients metabolic and bariatric procedures. Accurate follow-up data • Supervised registered nurse with experience, training, enables the comparison of outcomes data between sites and or certification in the care of metabolic and bariatric at the national level. The center must document a protocol patients to follow the long-term progress of all of their metabolic and • Patient or patient’s family bariatric patients. • Death certificates • Internet sources (such as death index, patient locator It is mandatory that all patients are followed through the 30 software, obituary listings) day, six month, and one year follow-up timeframes. Centers • Communication with other medical facilities must attempt to follow patients annually until the patient does not have an assessment completed for two consecutive follow-up timeframes. If a patient does not have a scheduled Documentation assessment within a follow-up timeframe, the center must contact the patient. Patients designated as lost to follow- • Long-term follow-up protocol. up must have a minimum of two attempts to contact the • Documentation of the required contact attempts for each patient for each follow-up timeframe. Contact attempts patient. must be documented in the MBSAQIP Registry. Once an appointment for an assessment has been made within the follow-up timeframe, no additional follow-up contact Measure of Compliance attempts are required for that follow-up timeframe. The center may cease attempts to contact patients after the patient • Provides documentation of a long-term follow-up is lost to follow-up or a no-show for two consecutive follow- protocol, including a protocol for maintaining or up timeframes (for example, a patient who does not return re-establishing contact with metabolic and bariatric for year two and year three visits). patients. • Provides proof that a minimum of two contact attempts Methods to obtain 30-day and long-term follow-up include, per follow-up period are documented for patients who but are not limited to, the following: are lost to follow-up (this is not required for patients • Physician assessment who remain lost to follow-up after two consecutive • Nurse practitioner assessment follow-up time periods).

Requirements for Follow-Up Attempts* Patient IDN 30-Day 6-Month 1-Year 2-Year 3-Year 4-Year 5-Year 6-Year 00001 No assessment No assessment No assessment x x x x x 00002 Assessment No assessment No assessment x x x x x 00003 Assessment Assessment No assessment No assessment x x x x 00004 Assessment Assessment Assessment No assessment No assessment x x x 00005 Assessment No assessment Assessment No assessment No assessment x x x 00006 Assessment No assessment Assessment No assessment Assessment No assessment No assessment x 00007 Assessment No assessment Assessment No assessment Assessment No assessment No assessment x 00008 Assessment Assessment Assessment No assessment Assessment Assessment Assessment Assessment

Assessment Patient is contacted and receives scheduled clinical assessment No assessment Patient is not seen for scheduled clinical assessment or Patient has no appointment scheduled; two attempts to contact patient must be documented x No further attempts to contact patient are required

*The table above provides an example of possible follow-up scenarios. Attempts to follow patients annually must continue beyond the six-year follow-up period until the patient is not assessed for two consecutive follow-up periods.

62 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Data Surveillance and Systems | Standard 6

6.3 Data Review

Definition and Requirements

All centers are required to monitor their data. Ongoing review of the semiannual risk-adjusted reports (SAR) and unadjusted outcomes data is critical for continuous quality improvement. Semiannual risk-adjusted reports (SAR) are released twice a year to participating centers that maintain a complete 30-day follow-up rate of greater than or equal to 80 percent. Unadjusted outcomes reports are available to all centers via the MBSAQIP Registry. Reports from the MBSAQIP Registry provide site-specific data for participating centers and the ability to benchmark outcomes against aggregate national comparison data. Online reports must be reviewed by the MBS Committee a minimum of three times annually, two of which must be reviews of the semiannual risk-adjusted reports (SAR).

Centers are exempt from demonstrating compliance with this Standard at their initial accreditation site visit, unless they have already received at least one semiannual risk- adjusted report (SAR). Once a center has received their first semiannual risk-adjusted report (SAR), full compliance with this Standard is required.

Documentation

• MBS Committee meeting minutes documenting review of data from the MBSAQIP Registry. • Copies of the center’s semiannual risk-adjusted reports (SAR).

Measure of Compliance

• Provides documentation that the MBS Committee reviewed reports from the MBSAQIP Registry a minimum of three times annually, two of which must be reviews of the semiannual risk-adjusted reports (SAR).

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 63 Standard 6 | Data Surveillance and Systems

6.4 Obesity Medicine Data Collection

Data Collection Methods Definition and Requirements Independent data collection for obesity medicine patients must be accomplished using one of the following methods. MBSAQIP Obesity Medicine Qualifications are separate Only one method of data collection is required. The choice and distinct from surgical and procedural accreditation. of data collection method is at the discretion of the Obesity Only MBSAQIP Comprehensive Centers and MBSAQIP Medicine Director (OMD). Comprehensive Centers with Adolescent Qualifications are 1. EMR Data Collection- Accredited centers with Obesity eligible to seek MBSAQIP Obesity Medicine Qualifications. Medicine Qualifications must document data collection and outcomes monitoring for obesity medicine patients Data collection and outcomes monitoring for obesity using an electronic medical record system. All required medicine patients is a critical component of tracking patient variables for data collection, as outlined above, must progress and identifying successful treatment strategies. be recorded during each patient appointment and However, only surgical and non-surgical procedures documented in the patient’s electronic medical record performed for the treatment of metabolic or obesity- within 90 days of patient contact. The EMR must be related diseases are eligible to be captured in the MBSAQIP accessible for basic reporting and data analysis to help Registry. Patients receiving non-procedural obesity improve patient care. medicine treatment at a MBSAQIP-Accredited center with 2. MBSAQIP Obesity Medicine Patient Tracker- Obesity Medicine Qualifications cannot be captured in the Accredited centers with Obesity Medicine MBSAQIP Registry, and instead must be captured using an Qualifications must document data collection and independent, local level data collection method. outcomes monitoring for obesity medicine patients using the MBSAQIP Obesity Medicine Patient Tracker. All MBSAQIP-Accredited centers with Obesity Medicine The MBSAQIP Obesity Medicine Patient Tracker is Qualifications must commit to independent, local level data a spreadsheet designed for data collection for obesity collection and outcomes monitoring for obesity medicine medicine patients. All required variables for data patients. The data collection method utilized must be collection, as outlined above, must be recorded during accessible for basic reporting and data analysis to help each patient appointment and documented in the improve patient care. MBSAQIP Obesity Medicine Patient Tracker within 90 days of patient contact. The MBSAQIP Obesity Required Variables Medicine Patient Tracker is available on the MBSAQIP The following patient variables must be captured for data website, facs.org/quality-programs/mbsaqip/resources. collection and outcomes monitoring for obesity medicine 3. Alternative Written or Electronic Method for Data patients: Collection- Accredited centers with Obesity Medicine • Patient information (Name, ethnicity, demographic Qualifications are allowed to design their own method information, etc.) to document data collection and outcomes monitoring • Height and weight at initial presentation for obesity medicine patients. The center-designed • Body mass index (BMI) at initial presentation system for data collection must provide reliable and • Body fat percentage at initial presentation easily accessible patient data in either a written or • Comorbidities at initial presentation electronic format for basic reporting and data analysis • Weight percentage change over time to help improve patient care. All required variables for • BMI change over time data collection, as outlined above, must be recorded • Body fat percentage change over time during each patient appointment and documented • Comorbidity change over time within 90 days of patient contact. • Anti-obesity medications • Complications and side effects of obesity medicine Obesity Medicine Data Capture treatment The Obesity Medicine Director (OMD) must ensure that obesity medicine data capture is executed as outlined above. Capturing additional variables related to patient health and The OMD is allowed to delegate the actual data capture satisfaction, and obesity medicine treatment is encouraged, process to a member(s) of the obesity medicine program but not required. Identifying additional variables for data capable of maintaining data capture as outlined above. There capture, beyond the required variables outlined above, is at is no requirement for a designated individual with specialized the discretion of the Obesity Medicine Director (OMD). training (such as a MBS Clinical Reviewer) to document and capture obesity medicine patient data.

64 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Data Surveillance and Systems | Standard 6

If the center chooses to have the current MBS Clinical Reviewer also capture data for the obesity medicine program, the center must provide a letter of attestation stating that the MBS Clinical Reviewer is supported with sufficient time and resources to complete all of their responsibilities for data capture to the MBSAQIP Registry, and for the obesity medicine program. The letter of attestation must be signed by the MBS Director, the OMD, and the MBS Clinical Reviewer.

Documentation

• Written or electronic records of data collection and outcomes monitoring for obesity medicine patients. • Identified member(s) of the obesity medicine program capable of maintaining data capture. • If applicable, a letter of attestation signed by the MBS Director, the OMD, and the MBS Clinical Reviewer.

Measure of Compliance

• Provides documentation of written or electronic records for data collection and outcomes monitoring for obesity medicine patients. • Provides documentation that all required patient variables outlined above are being recorded for obesity medicine patients. • Provides proof that an approved data collection method is in use for data collection and outcomes monitoring for obesity medicine patients, which is accessible for basic reporting and data analysis to help improve patient care. • Provides proof that an identified member(s) of the obesity medicine program is maintaining data capture as outlined above. • Provides documentation, if applicable, of a letter of attestation signed by the MBS Director, the OMD, and the MBS Clinical Reviewer stating that the MBS Clinical Reviewer is supported with sufficient time and resources to complete all of their responsibilities for data capture to the MBSAQIP Registry and for the obesity medicine program, if the MBS Clinical Reviewer is also responsible for data capture for the obesity medicine program.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 65 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 7 Quality Improvement Rationale Processes for identifying adverse events and implementing subsequent corrective action plans, measurable through patient outcomes, are inherent cornerstones of continuous quality improvement. Problem resolution, outcomes improvement, and assurances of patient safety (“loop closure”) must be readily identifiable through structured quality improvement initiatives.

In support of these efforts, the MBS Director and the MBS Committee at each center must develop a culture of collaboration in order to report, analyze, and implement strategies based on data to drive improvement in the quality of care offered to metabolic and bariatric patients. While major quality improvement initiatives such as decreasing surgical site infections, leaks, or venous thromboembolism prophylaxis are important, equally important is the examination of pathways of care in order to maximize the patient experience and effectiveness of metabolic and bariatric procedures. Continuous quality improvement must be reflected in the results of such efforts by the MBS Committee. Please see the MBSAQIP website, facs.org/quality-programs/ mbsaqip/resources for further information and resources regarding quality improvement. Quality Improvement | Standard 7

7.1 Adverse Event Monitoring

Definition and Requirements Documentation

Patient safety and adverse event monitoring must be • Protocol for adverse event notification and review. implemented by all MBSAQIP-Accredited centers through • MBS Committee meeting minutes documenting the the MBS Committee, and led by the MBS Director. For the review of adverse events. purposes of patient safety and adverse event monitoring, it is the responsibility of the MBS Committee to: 1. Establish and maintain a protocol for notifying Measure of Compliance surgeons and proceduralists of adverse events and to review and discuss the patient’s care within the MBS • Provides documentation of a protocol for the Committee when an adverse event occurs. Examples notification of adverse events and the subsequent review of adverse events include, but are not limited to: process. complications, readmissions, reoperations, prolonged • Provides documentation in a HIPAA-compliant length of stay, postoperative morbidity, unplanned manner of the minutes of all MBS Committee meetings admission to ICU, and mortality. indicating that all of the following were reviewed: 2. Review all mortalities occurring in-hospital or within 1. All adverse events as part of a protected, peer review the first 90-day postoperative period. Such mortalities process must be reviewed within 60 days of discovery. This 2. All in-hospital or 90-day mortalities, if any, within review must occur for all mortalities that meet the 60 days of discovery above criteria, without exception. 3. Semiannual risk-adjusted reports (SAR) 3. Review outcomes data on a regular basis, as outlined in Standard 6.3. –– This review of outcomes data must be based on data from the MBSAQIP Registry. However, the review of additional data may also help in determining root causes for adverse events.

The MBS Committee meeting minutes must document when adverse event monitoring and review occurs. The meeting minutes must be completed in a HIPAA-compliant manner and with respect for the protected, peer review process.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 69 Standard 7 | Quality Improvement

7.2 Quality Improvement Initiatives

safety when warranted. If further investigation reveals a QI Definition and Requirements initiative addressing a high outlier status is unwarranted (for example, concurrent data shows subsequent resolution of the The goal for MBSAQIP-Accredited centers is to provide safe, issue), the center may select an alternative QI initiative driven efficacious, and high-quality care to each patient at all times. by other data or process reviews. However, the center must To achieve this goal, it is imperative to develop a culture of provide written justification to support this decision. collaboration and safety among all MBS Committee members at the center. Quality improvement (QI) emphasizes a Initial centers, and renewal centers that do not have a high continuous, multidisciplinary effort to improve the process outlier status on the semiannual risk-adjusted report (SAR), of care and its outcome. Thus, QI must be supported by a must develop quality improvement initiatives prioritizing reliable method of data collection that consistently obtains other issues related to clinical outcomes and patient safety. valid and objective information necessary to identify If no such issues are readily identifiable, QI initiatives must opportunities for improvement at the center. The semiannual target other areas for improvement, including, but not risk-adjusted reports (SAR), non-risk-adjusted reports, and limited to: internal processes, clinical pathways, patient other data sources (for example, patient experience scores) education, patient experience, or other relevant issues are valuable tools to evaluate areas for improvement for the related to providing safe, efficacious, and high-quality care to center and must be used to identify pertinent QI initiatives. metabolic and bariatric patients. These initiatives must change structure, processes, and/or clinical pathways within the center. Quality Improvement Outline These 6 steps outline the basic process for completing a With oversight from the MBS Director, all MBSAQIP- quality improvement initiative that satisfies the requirements Accredited centers must measure, evaluate, and improve outlined above. Further information about quality their performance through at least one quality improvement improvement, including a detailed review of this 6 step initiative each year. The timeline for completion of each QI process, can be found on the MBSAQIP website, facs.org/ initiative is variable depending on the scope of the project, quality-programs/mbsaqip/resources. and must be determined by the MBS Committee. However, a new QI initiative must be implemented each year, even if a 1. Review Data previous initiative is still underway. a. Semiannual risk-adjusted reports (SAR) b. Non-risk-adjusted reports Centers must adopt a consistent methodology for quality c. Internal data improvement initiatives. The methodology may vary 2. Identify the Problem from center to center depending on the unique needs and a. High outlier status expectations of each. Various QI methodologies can be b. Other areas for improvement adopted to support quality improvement initiatives. Further 3. Propose Intervention information about QI methodologies can be found on the a. Discuss contributing factors MBSAQIP website, facs.org/quality-programs/mbsaqip/ b. Root cause analysis resources. 4. Choose Quality Improvement Methodology a. MBSAQIP-Accredited centers are able to use any Renewal centers must first review their risk-adjusted and consistent quality improvement methodology that non-risk-adjusted clinical outcomes data provided by satisfies their unique needs the MBSAQIP Registry to identify quality improvement b. Establish a timeline for review and metrics to track initiatives, and must prioritize QI initiatives that focus on progress improving surgical outcomes. Centers found to be a high 5. Implement Intervention & Monitor Data outlier on the semiannual risk-adjusted report (SAR) a. Consistently implement the intervention must develop a QI initiative designed to address the high b. Monitor data outlier status. If the center is a high outlier in more than one 6. Present Results model on the semiannual risk-adjusted report (SAR), the a. Gather all documentation and data MBS Committee must prioritize these clinical issues and the b. Review progress next QI initiative must address the greatest risk to patient c. Summarize the findings and results of the quality safety. Although only one QI initiative is required each year, improvement initiative the MBSAQIP encourages the use of multiple QI initiatives to address issues related to clinical outcomes and patient

70 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Quality Improvement | Standard 7

Documentation

• At least one QI initiative per year, implemented using a consistent quality improvement methodology. • MBS Committee meeting minutes documenting review of QI initiatives.

Measure of Compliance

• Provides documentation for at least one QI initiative per year, which outlines how the center measured, evaluated, and improved their performance through the implementation of a consistent quality improvement methodology. • Provides proof that any high outlier status identified on the semiannual risk-adjusted report (SAR) was prioritized for a quality improvement initiative. • Provides documentation of MBS Committee meeting minutes which review how the MBS Committee members identified, implemented, and monitored QI initiatives.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 71 Standard 7 | Quality Improvement

7.3 Annual Compliance Reports (ACRs)

Definition and Requirements

Centers are exempt from demonstrating compliance with this Standard at their initial accreditation site visit. Once a center has achieved MBSAQIP Accreditation, full compliance with this Standard is required.

The MBS Director and MBS Coordinator are required to submit an Annual Compliance Report (ACR) to the MBSAQIP in the second and third years of the triennial reaccreditation cycle. The ACR is due during the anniversary month in which the center was first accredited by the MBSAQIP. An ACR is not required for years when the center is due for a site visit.

Sample Schedule for Site Visits and ACR Submission April 2015 Site Visit April 2018 Site Visit April 2016 ACR April 2019 ACR April 2017 ACR April 2020 ACR

The ACR contains an attestation of compliance with all applicable Standards for the center’s designation level, as well as mandatory information about data entry, procedure volumes, and other questions pertaining to the MBSAQIP Accreditation.

All accredited centers are notified by the MBSAQIP before the ACR must be submitted. This notification contains all the necessary information on how to submit the ACR to MBSAQIP.

Documentation

• Copies of the Annual Compliance Reports that were submitted to the MBSAQIP.

Measure of Compliance

• Provides documentation that complete Annual Compliance Reports were submitted to the MBSAQIP within the accreditation anniversary month in the second and third year of the triennial reaccreditation cycle.

72 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Quality Improvement | Standard 7

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 73 AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS AMERICAN COLLEGE OF SURGEONS A AMERICAN COLLEGE OF SURGEONS METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM

STANDARD 8 Education: Professional and Community Outreach Rationale Continuous outreach to metabolic and bariatric patients through regularly scheduled, organized, and supervised support groups is critical for maintaining long-term patient engagement and success. Support groups create an environment for both health care providers and patients to offer ongoing education and encouragement. Professional and Community Outreach | Standard 8

8.1 Support Groups

Definition and Requirements

MBSAQIP-Accredited centers must provide regularly scheduled, organized, and supervised support groups for metabolic and bariatric patients. Regularly scheduled support groups must be made available a minimum of every two months and can be in-person, web-based, or teleconferenced. The surgical practice(s) and/or center are allowed to organize support groups, but the entity responsible for administering each support group must be clearly identified. A licensed health care provider must be present to supervise all support groups. The center’s MBS Committee must determine the required credentials for health care providers supervising support groups. The center must provide patients with information regarding all of their options for support groups.

All support group activities must be documented, including group location, meeting time, supervisor, curriculum, and number of people in attendance. Other activities, including online forums, exercise instruction, and clothing sales must be noted but do not require full documentation.

Documentation

• Support group meeting schedule. • Support group meeting documentation: time, location, agenda, attendance, and supervisor. • Credentials of the support group supervisor.

Measure of Compliance

• Provides documentation that support groups are held at least every two months (in-person, web-based, or teleconferenced), with proper documentation of the meeting time, location, agenda, attendance, and supervisor. • Provides documentation of the credentials for the licensed health care provider who is present to supervise support groups.

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 77 Accreditation Definitions

Accreditation Status Definition Accredited The center has completed a site visit and demonstrated full compliance with all applicable Standards for their designation level, as outlined in the Optimal Resources for Metabolic and Bariatric Surgery, and has provided all requisite documentation to support compliance.

Accredited— The center is non-complaint with one or more applicable Standards. Corrective Action Required The center will receive an Accreditation Report documenting all non-compliant Standards and will be given a corrective action timeframe to provide all necessary data and documentation Renewal Applicants Only required to verify full compliance with all applicable Standards. The timeframe for corrective action is dependent on the non-compliant Standard(s).

During the corrective action timeframe, the center will continue to be recognized as a MBSAQIP- Accredited center. The center must continue to submit clinical data to the MBSAQIP Registry. Not Accredited— The center is non-complaint with one or more applicable Standards. Accreditation is pending until Corrective Action the center resolves all non-compliant Standards identified during the application process or at the Required time of the site visit.

Initial Applicants Only The center will receive an Accreditation Report documenting all non-compliant Standards and will be given a corrective action timeframe to provide all necessary data and documentation required to verify full compliance with all applicable Standards. The timeframe for corrective action is dependent on the non-compliant Standard(s).

During the corrective action timeframe, the center will not be recognized as a MBSAQIP- Accredited center. The center must continue to submit clinical data to the MBSAQIP Registry. Not Accredited The center is unable to demonstrate compliance with the required Standards applicable to the MBSAQIP designation level sought.

The center must submit a new Pre-Review Questionnaire (PRQ) if they wish to continue pursuing MBSAQIP Accreditation.

78 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons Accreditation Process Overview

MBSAQIP Accreditation Process for Initial Applicants MBSAQIP Reaccreditation Process for Renewal Applicants

Application Pre-Review Questionnaire (PRQ) • Review MBSAQIP Standards to determine eligibility • Review MBSAQIP Standards to confirm ongoing and appropriate designation level for your center eligibility and appropriate designation level for your • Submit online application (available at mbsaqip.org) center • Upon approval of application, center will be sent login • Renewal PRQ becomes available 6 months prior to information for the online accreditation portal accreditation anniversary date Pre-Review Questionnaire (PRQ) • Log in to online accreditation portal to complete and submit PRQ and confirm center information is up to • Log in to online accreditation portal and complete and date submit PRQ • Center pays any outstanding annual participation • Center pays annual participation fee and executes fees and executes renewal contracts prior to PRQ contracts prior to PRQ submission submission • Center must meet all applicable Standards at the time • Center must meet all applicable Standards at the time of PRQ submission of PRQ submission • MBS Clinical Reviewer is registered for training Site Visit Site Visit • Center is assigned a surgeon Site Visit Reviewer after • Center is assigned a surgeon Site Visit Reviewer and PRQ submission and must complete a site visit within must complete a site visit within 6 months of PRQ 30 days of accreditation anniversary date submission Outcome • MBS Clinical Reviewer must successfully complete online training modules and begin data entry to • Center will be notified of accreditation decision and MBSAQIP Registry prior to site visit receive the Accreditation Report approximately 8-12 Outcome weeks after the site visit • If accredited, the center is renewed for a new 3-year • Center will be notified of accreditation decision and term from the date of initial accreditation receive the Accreditation Report approximately 8-12 • Center submits Annual Compliance Report (ACR) at weeks after the site visit the first and second anniversary of initial accreditation • Center’s accreditation is effective retroactive to the and submits renewal application at 3 years date of the site visit and remains accredited for a 3-year term • Center submits Annual Compliance Report (ACR) at the first and second anniversary of initial accreditation and submits renewal application at 3 years

American College of Surgeons | 2019 Standards | Optimal Resources for Metabolic and Bariatric Surgery 79 American College of Surgeons 633 N. Saint Clair St. Chicago, IL 60611-3295 facs.org

80 Optimal Resources for Metabolic and Bariatric Surgery | 2019 Standards | American College of Surgeons